Category: Blog

When the Soviet Union invaded Finland in 1939, Russian leadership thought the country would be easily conquered.

After all, the Soviets had one of the world’s largest militaries, while Finland had one of the smallest. The Finns were monumentally outmanned and outgunned. 

Yet the Finns put up a gritty, prolonged, improbable resistance that surprised and inspired the entire free world.

The secret to the Finns’ stand was a quality they call sisu.

There isn’t a single word in English with a literal parallel to sisu, and even in Finland it stands in for a constellation of traits, which includes stoic determination, hardihood, bravery, willpower, tenacity, guts, and resilience. Grit.

We’ve created two items in the Art of Manliness shop that honor the guerrilla ski troops who faced down Goliath with big hearts and flinty courage.

Sisu Long-Sleeve Thermal

A few months ago we introduced our sisu long-sleeve thermal shirt. Going into spring (though it seems like it’s still going to be cold for awhile in places!), the shirts are now 25% off. Grab ’em at a discount while you can! Sale ends March 31, 2018.

Sisu Morale Patch

We’re now introducing a sisu morale patch. Stick this 2″ x 3″ embroidered patch with velcro backing on your ruck pack or hat to serve as an all-season reminder to live with grit.

The post Sisu Thermals 25% Off; Plus Sisu Morale Patches Now Available! appeared first on The Art of Manliness.

What does it mean to be “self-reliant”? Is it living off the grid in a cabin in the remote wilderness? Doing everything yourself, and pulling yourself up by your bootstraps? 

Or is there a deeper and even more profound meaning to be grasped?

In The Pocket Guide to Self-RelianceKyle Eschenroeder makes the case that self-reliance is much more than being physically self-sufficient or even doing things on your own. More than keeping yourself physically independent, it’s about keeping your mind sovereign. Self-reliance is about living a life in which you make decisions and opinions with primary respect to your own experience of the world. You trust yourself. You’re true to yourself.

Developing this kind of self-trust is harder than ever in a modern world where you’re constantly bombarded with outside opinions, and tempted to live an other-directed life. But it’s a quality that’s also more vital than ever.

In this pocket-sized book (measuring 3.5″ x 5″, it’s even smaller than our Pocket Guide to Action), Eschenroeder lays out what most people get wrong about self-reliance and what it really means. He also provides both inspiring meditations and brass-tacks advice on how to attain greater self-reliance in your own life. Carry The Pocket Guide to Self-Reliance wherever you go, so whenever you begin to doubt yourself, you can read an excerpt and stay your self-chosen course. 

Buy the Book Today!

Special Offer!

To help you really think about the ideas in The Pocket Guide to Self-RelianceKyle has put together 31 journal prompts to help you reflect and take action on becoming a more self-reliant man. Everyone who buys a copy of The Pocket Guide to Self-Reliance will receive a free PDF of the journal prompts. Print it off and answer the questions as you read though the book.

Buy the Book Today!

The post Now Available: The Pocket Guide to Self-Reliance appeared first on The Art of Manliness.

What are the symptoms of Uterine Fibroids? Addressing your concerns immediately can save you years of future pain and infertility. Ask your doctor any and all questions. The more you know about fibroids, the better you can understand which fibroid treatment is right for you. To get in touch with the best fibroids doctor in Los Angeles, contact the Fibroid Treatment Collective to consult with Dr. McLucas.

When speaking with your doctor, you may want to begin by asking how, and why fibroids may be growing in your uterus. While each woman’s case is unique, your doctor may tell you that fibroids have been linked to increased estrogen, and for many women fibroids begin during pregnancy, and before menopause. If your symptoms began around these times fibroids may be the cause.

give your doctor an overview of your symptoms, in addition to asking any specific symptom related questions. If you are experiencing an unusually heavy menstrual cycle, ask about the differences between a very heavy period, and fibroid related bleeding. It may be difficult to tell for most women on their own, so be as thorough as possible when explaining your symptoms. Fibroid related bleeding usually results in large clots, chunks of tissue in the blood, irregular intensity of flow, and a longer-lasting period.

If your stomach is enlarging unexpectedly, ask your doctor if it could be related to fibroid growth. Fibroids may be the cause if you have gained weight with no apparent dietary changes, are not pregnant, and are experiencing abdominal bloating. In some cases, fibroids have been known to press on organs and nerves, causing back and leg pain, and constipation, and urinary frequency.

After going over possible fibroid symptoms with your doctor, ask about your treatment. A hysterectomy and myomectomy are common surgical procedures that many women undergo to remove the uterus or fibroids. However, be sure to also ask your doctor about non-surgical treatments, which are often a preferable option for women who want children or are looking for an alternative to surgery.

Medical therapies, which include birth control pills, progestins, gonadotropin-releasing hormone (GnRH), analogues, selective estrogen receptor modulators (SERMs), selective progesterone receptor modulators (SPRMs), and aromatase inhibitors have been used to treat fibroid symptoms, but have also shown side effects. If you are interested in medical therapy, it’s important to ask about the risks involved and how well they treat fibroids. For instance, progestins alone (oral, intramuscular, or intrauterine) may control bleeding by reducing endometrial hyperplasia, but their use will not result in tumor shrinkage and may, in fact, induce tumor growth.

Ask your doctor about uterine fibroid embolization, another non-surgical option that has helped over 90% of patients experience relief from their symptoms and shown significant fibroid shrinkage. If you are interested in any of these treatment options, remember to be clear with your doctor about each of your symptoms as well as any concerns or treatment preferences you may have, to help you make an informed decision. To learn more about fibroid symptoms and to get in touch with the best fibroids doctor in Los Angeles, contact us at (888) 296-9422.

The post Questions to Ask Your Doctor If You are Experiencing Fibroid Symptoms appeared first on Treatment for Uterine Fibroids with Embolization (UFE).

By Kristen BoothFDA Increases Focus on Generic Drugs with New RegulationThroughout 2017 the FDA has increased the attention being paid to generic drug products.  In 2015, there were two guidance documents issued related to generic products.  In 2016, there were seven.  In 2017, there were 15 guidance documents (including final, draft, and revised guidance documents) issued regarding ANDAs and/or generic drug products.  Even more noteworthy is the fact that 11 of these 15 documents have been issued since October 1st.  Furthermore, the FDA published it’s first generic-related guidance document of 2018 in the first week of the year.

What is the story behind the FDA’s recent focus on generic products? Why has there been so much activity surrounding generics lately?  There are a few likely reasons for this, and here’s what we think they are:

Reauthorization of the Generic Drug User Fee Amendments (GDUFA)

On August 18, 2017, the FDA Reauthorization Act (FDARA) was signed into law, officially reauthorizing GDUFA through September 30, 2022.  The reauthorization, known as GDUFA II, took effect on October 1, 2017, and is intended to supplement congressional funding for the Agency’s review of generic drug applications.

There were three key changes introduced with the reauthorization of GDUFA, which are a large reason that there have been an abundance of generic-related guidance and draft guidance documents published since GDUFA II took effect.  These changes include:

  1. Fee structure
  2. Review of priority submissions
  3. The introduction of Pre-ANDA programs

Fee Structure

A majority of the fees are the same in both GDUFA I and II; however, it is important to note a few major differences, which include:

  • Contract manufacturing facilities are now included in the facility fee.
    • Facility fees for contract manufacturing facilities are 1/3 of the amount of the fee for non-contract manufacturing facilities
    • The fees for foreign facilities is $15,000 higher than those for domestic facilities
  • Prior approval supplement (PAS) fee has been eliminated
  • New program fee for all approved ANDAs has been added
    • The ANDA program fee assesses a fee to generic drug makers based on the number of approved ANDAs they held as of the October 1st due date
    • ANDAs for which a written request for withdrawal of approval is submitted by April 1st of the previous FY are not included in the total ANDA number
  • The penalties imposed on sponsors who fail to pay fees remain the same with the following additions:
    • Sponsor will now be added to the publicly available arrears list
    • FDA will refuse to receive (RTR) any future ANDAs from that sponsor
    • Any and all drugs marketed under an approved ANDA held by the sponsor or its affiliates will be deemed misbranded

Review of Priority Submissions

Under GDUFA II, ANDA submission and amendments, as well as PAS submissions and amendments are categorized as either standard or priority.  The reauthorization brakes down the different submissions into more refined categories, allowing the Agency to set appropriate review times for each subset of submissions depending on what it is, how important it is for public health, and how lengthy the submission is.

GDUFA II also provides detailed overview of the timeframes in which the FDA will review these submissions, which have been shortened in an attempt to improve patient access to generic products.  This is important, as it will help hold the Agency more accountable, and it will help to eliminate the FDA’s backlog of ANDAs and prevent such a backlog from occurring in the future.

Pre-ANDA Program

The Pre-ANDA program was created to clarify regulatory expectations for potential applicants early in the development process.  For complex generic products, sponsors can now request a Pre-ANDA meeting.  During this meeting, the sponsor will meet with the Agency to discuss and review its product’s development and receive advice from the FDA regarding ANDA development programs.  Meetings can be held prior to submission of the ANDA to discuss the content and format of the application, or mid-review to discuss any deficiencies, concerns, or next steps that have been identified by the Agency.

In addition to the Pre-ANDA program, an ANDA review program was also established.  This program was developed with the goal of expanding the frequency and scope of reviewer-sponsor communication.  Under this program, FDA will allow sponsors to have an opportunity to correct deficiencies by communicating any issues in the middle of the review process rather than at the end in the Complete Response Letter (CRL).

Although there were only three major changes implemented within GDUFA II, there are a lot that goes along with each of these changes.  As such, a great number of 2017’s guidance documents, specifically those issued after October 1st, are a direct result of the reauthorization of GDUFA.

Efforts to Reduce ANDA Backlog

It is widely known that the FDA has had a backlog of ANDA submissions for quite some time now.  The size of the backlog has varied over time, reaching nearly 2,900 pending applications at the height of the issue back in 2012.  Since then, the Agency has taken extreme measures to reduce the overflowing queue of pending applications.  Although these efforts have been successful, there are still more applications awaiting review than the Agency would like to have on its desk at any given time.  As such, reducing, and ultimately eliminating, this backlog is still a primary goal of the FDA.  With this still on the Agency’s to do list, it is to be expected that there would be some extra attention being paid to generic drugs, resulting in an above average amount of relevant guidance documents being released.

Drug Competition Action Plan

Last but certainly not least, the final cause of the increased generic regulation is the FDA’s recent acknowledgement that there is an issue concerning drug competition and patient access to certain drugs.

High Drug Prices are Limiting Patient Access

In a blog post published by the FDA Voice on June 21, 2017, FDA commissioner Scott Gottlieb, MD stated that “too many patients are being priced out of the medicines they need.”  Furthermore, he went on to note that, although the Agency is not directly involved in drug pricing, it can address the issue by “facilitating increased competition in the market for prescription drugs through the approval of lower-cost, generic medicines.”  He noted that, “innovation in pharmaceutical development is essential because it creates new and sometimes life-saving therapies. But access to lower-cost alternatives, once patent and exclusivity periods lapse, also is critical to the nation’s health.”

FDA’s Solution

In his blog post, Dr. Gottlieb stated that there are a number of scientific and regulatory obstacles inhibiting generic competition.  As such, these barriers are delaying and, in some cases, denying patient access to more affordable drugs.  This is an issue that requires immediate attention.

On June 27, 2017, a press release was issued from the FDA, announcing a number of steps the Agency is taking under its new Drug Competition Action Plan to “increase competition in the market for prescription drugs and facilitate entry of lower-cost alternatives.”

The Drug Competition Action Plan is just one part of the FDA’s solution to this problem.  In addition, the FDA is also taking the following actions to solve the issue at hand:

  • On July 18th, a public meeting was held by the FDA, where it asked for input on how and where the FDA’s current rules (e.g., standards and procedures related to generic drug approvals) are creating obstacles for generic drug makers.
  • In an attempt to encourage the development of generic products, the FDA “posted a list of branded drugs that have no listed patents or exclusivities and for which the agency has yet to approve a generic drug application.” Furthermore, the Agency “intends to expedite the review of any generic drug application for a product on this list to ensure that they come to market as expeditiously as possible.”
  • The FDA announced a change to is policy regarding the way it prioritizes the review of ANDAs that are submitted. In this announcement, the Agency stated that it “will expedite the review of generic drug applications until there are three approved generics for a given drug product.”

As the Agency works to improve patient access to generic drugs and provide patients with more cost-effective options, the amount of information being released has increased.  In the form of both draft and final guidance documents, as well as the proposal of new legislation and FDA rules, and so much more, the Agency’s dedication to facilitating competition in the market is the one of the main reasons behind the increase in generic-related activity in 2017.

Draft & Final Guidance Documents Issued in 2017

It is clear that there a number of factors causing the significant spike in generic-related activity that occurred in 2017, however we have yet to talk about the actual topics being addressed.  As such, the following list includes the topic of each guidance document that was issued last year:

  1. 180-Day Exclusivity: Questions and Answers – Draft Guidance issued on January 12, 2017
  2. Referencing Approved Drug Products in ANDA Submissions – Draft Guidance issued on January 13, 2017
  3. Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA – Draft Guidance issued on January 13, 2017
  4. ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin – Draft Guidance issued on October 2, 2017
  5. ANDA Submissions – Refuse-to-Receive Standards: Questions and Answers – Draft Guidance issued on October 2, 2017
  6. ANDA Submissions — Amendments to Abbreviated New Drug Applications Under GDUFA – Draft Guidance issued on October 2, 2017
  7. Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA – Draft Guidance issued on October 2, 2017
  8. ANDA Submissions – Prior Approval Supplements Under GDUFA – Final Guidance issued on October 4, 2017
  9. Completeness Assessments for Type II API DMFs Under GDUFA – Final Guidance issued on October 4, 2017
  10. Determining Whether to Submit an ANDA or a 505(b)(2) Application – Draft Guidance issued on October 11, 2017
  11. Requests for Reconsideration at the Division Level Under GDUFA – Draft Guidance issued on October 11, 2017
  12. Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA – Draft Guidance issued on October 13, 2017
  13. Controlled Correspondence Related to Generic Drug Development – Draft Guidance issued on November 2, 2017
  14. General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products – Final Guidance issued on November 21, 2017
  15. Information Requests and Discipline Review Letters Under GDUFA – Draft Guidance issued on December 15, 2017

In addition, there has also been one generic-related guidance document published so far this year.  On January 3, 2018, the FDA published a draft guidance entitled “Good ANDA Submission Practices,” and if 2017 was any indication of what is to come, it just the first of many to come throughout the year.

We Can Help get your Generic Drug Approved by FDA

Are you in the process of developing a generic drug product? Do you need help preparing and submitting your ANDA to the FDA? We can help. Contact us today to learn more about our services and how we can help you obtain approval from the Agency.

The post FDA Steps up its Game on Generic Drugs: The Story Behind the Recent Focus on Generic Products appeared first on Weinberg Group.


by Christina Tidwell, AARDA guest blogger

Swimming Pool Gratitude

What if today, instead of diagnosing, monitoring, analyzing, treating and trying to fix your chronic illness you took a moment to step back, do nothing and simply be thankful for its place in your life. Yes, thankful for the thing that causes you pain, fatigue, confusion, loss of control and at times suffering. If you’re all “Yeah whatever lady, I didn’t ask for this, you don’t know what it’s like,” hear me out.

Illness is our body telling is that something is out of balance. It’s our body trying to get our attention so we can work towards fixing the imbalance. Having an illness in any form is not something anyone asks for, but if we can view illness as an opportunity to slow down, quiet down, and listen to what is going on internally it can be used as a great tool for healing and personal growth.

Illness, when simply observed with kindness and viewed without judgement can provide us with huge insights into the very core of ourselves.  It can act as a catalyst for personal awakening and growth because it forces us to become really aware of what is going on in our bodies and our lives at the most basic level.  As a busy society, we get pretty good at ignoring the subtle signals our bodies send us when we are burnt out and trying to keep up with the pace of life, and dulling them down when they become inconvenient. As Lissa Rankin eloquently states in her book Mind Over Medicine,

“Illness offers us a precious opportunity to investigate our lives without judgement, diagnose the root cause of what might be contributing to an illness, realign ourselves spiritually, and do what we can to make our bodies ripe for miracles.” – Lissa Rankin, MD

More often than not in life great catalysts of change come in the form of tragedy or sadness.  Illness can be one of these powerful vehicles of change if we let it.

Those who have chronic illness, whether you like it or not, have to become masters at identifying subtle cues in the body and strengthening this mind body connection as a survival mechanism.  This can come in the form of paying attention to food and what we put into our bodies, identification of environmental triggers for disease, knowing when to rest and when to keep moving, etc. Although this vigilance can be tiring, annoying, and cumbersome at times it’s ultimately one of the key pieces of living a healthy, robust life.

And Here You Are Living


Here are a few things that having a chronic disease has given me personally:

  • A strengthened connection between how I feel and what is going on in my body in order to detect imbalances before they become unmanageable.
  • My life calling and career path in health and wellness.
  • The ability to be a better nurse and healer for others because of a deeper understanding of the illness experience.
  • A true appreciation for food and how it’s the key to good health.
  • Greater connection to nature and the world around me through using food as nourishment and medicine.
  • A more grounded outlook on life and the things that truly matter.
  • The deeper ability to understand who I am and what I value at my core (a work in progress).
  • The ability to know when I need to slow down and take care of myself rather than push through and the wisdom to not judge myself either way (another work in progress).
  • An open mind about the myriad methods of healing, conventional and alternative.
  • Connection to a community of like-minded individuals who want to change the way chronic disease is managed in our current health care system.
  • A fierce appreciation for health, energy and good times!

So today I give you permission (you may totally not need it from me but, hey, sometimes it’s nice to hear!) to give yourself a break, do nothing, and know that what you are doing is enough. Because, OMG it can get overwhelming to be in charge of monitoring and healing these complex bodies of ours on or own.  I encourage you to take a moment today to think about or write down what you are thankful for about having an illness.   Or if not an illness just something traumatic that happened to you where you made it out alive (and if you’re reading this you are most certainly alive). If anything just this act of positive thinking can pull you out of a rut if you are feeling stuck. As my girl Lissa Rankin says,

“Gratitude keeps you optimistic, and as we’ve seen, evidence shows that optimism improves your health. When you focus on gratitude, positive things flow in more readily, making you even more grateful. As long as you keep your gratitude vessel full, you’ll avoid the unhealthy plunge into dark places.” – Lissa Rankin, MD

You may not be in a place where gratitude feels possible right now. Maybe the burden of your disease is greater than anything else and that is ok. No matter where you are today, simply try to take one moment to listen to what your body is telling you without judgment. See if you come up with something you weren’t aware of before and see if there is a tiny space for gratitude just for having this moment. One day you will be able to find one shred of it and it may make all the difference.


xx Christina Tidwell, MN, RN

The post “On Gratitude for Illness” from Christina Tidwell appeared first on AARDA.

Last year we started The Strenuous Life: an online/offline platform that’s like a scouting program for grown men. Each month, members receive The Strenuous Life Bugle, a newsletter that highlights what’s been going on at TSL. We thought AoM readers might enjoy a peek at it. If you’re interested in becoming a member yourself, sign up for updates here; the next enrollment opens at the end of March.

Geographic Group Meet-Ups From Last Month

This year, we designated the third Saturday of every month as “Strenuous Saturday” – the official monthly meet-up day for members of TSL.

Jan 20th was our Inaugural Strenuous Saturday and it was a big success! 30+ meet-ups took place across the globe, with members meeting together to exercise, hike, work on badge requirements, and do community service.

Here are just 5 of the meet-ups that took place last month:

Illinois Meet-Up

Members of the IL contingent of TSL met up for rock climbing at the Vertical Heights gym in Glendale Heights. Afterwards, they went to a brewery for a late lunch, beers, and conversation.

Germany Meet-Up

Three members of the fledgling Germany TSL contingent inaugurated their first meet-up with a ruck around a park. Afterwards they shared a meal and made plans to meet up again.

Oregon Meet-Up

@lessandoz, @chase_ted, @jtrabue, @arg, @jmcneal, @jcuellar, @jared, and @trulmy1 gathered for a “Gentleman Barbarian” meet-up, so-called for its combination of culture and physical exercise. The men first gathered at Hallie Ford Museum of Art in Salem before taking a ruck/hike at Minto-Brown Island Park in the Willamette River. Afterwards they adjourned to a brewpub for dinner and drinks.

Colorado Meet-Up

TSL members in the Denver area met up at the BluCore shooting range to work on requirements for the Sharpshooter Badge. Afterwards, the guys went out for beer.

Tennessee Meet-Ups

Tennessee boasted not just one but two meet-ups.

Members in Nashville hiked the Volunteer Trail in Hermitage.

While members in Chattanooga met together at the Chattanooga National Cemetery to perform community service; they helped to retrieve and dispose of the 19,000 wreaths laid at markers last December.

The next Strenuous Saturday is February 17th. You can see a list of scheduled events on the TSL homepage, and also check what’s going on by visiting the forum of your specific Geographic Group. I’ve noticed that several Geographic Groups have started using Whatsapp to facilitate communication and your group may want to consider implementing something like that as well.

Make your best effort to attend a meet-up in your area. It’s always tempting to follow the path of least resistance and just stay home and laze about. Embrace the friction and get out there to do something cool and meet your fellow Strenuous Lifers!

Badge Work

How’s your badge work been going? Here’s a look at some of the things your fellow TSL members have been working on:

@joseph-vandeventer, with a bodyweight of 180-lbs, hit his 1 rep max goal on the squat — 275 lbs — for the Barbell Badge, @amorse26 read Education of a Wandering Man for the Gentleman Scholar Badge, @s-c-hughes visited various sites in Washington D.C., including the White House, for the Citizenship Badge, and @thomaswsdyer made a pot roast for the Kiss the Chef Badge.

@wandering-traveler hosted a poker game for the Host Badge, @the-winter-fox replaced a window pane for the Handyman Badge, @cssl completed a GoRuck Tough for the Rucking Badge, and @wedge played the guitar for the Music Badge.

@alan-meyer started in on skiing 200 miles for the Mountain Ranger Badge (he’s up to 18 and counting!), @lbridgeman practiced his penmanship, along with his two boys, for the Penmanship Badge, @y2pascoe changed the air filter on his car, saving himself $60, for the Gearhead Badge, @clarkp practiced tying knots for the Knotsmanship Badge.

@armstrong went skeet shooting for the Sharpshooter Badge, @gentleman-scholar-beast-brooklyn held his 11th family meeting for the Paterfamilias Badge (combining it with their monthly game night, a tradition also started for the badge), @ronc, though he had already taken the MSF Basic Rider Course years ago, in the spirit of strenuosity, took the Basic E-course for the Easy Rider Badge, and @gentlemark gave a speech at his church for the Orator Badge.

Class Callouts

Classes 000, 003, 006, and 013 finalized their Class’ logo designs. These designs are being turned into patches, stickers, t-shirts, etc., according to each respective Class’ desires.

Once your Class has finalized a logo, let me know, as I can swap it out for the default TSL logo on your forum, like this:

Several Classes have started book clubs. As mentioned last time, Class 013 started one, and chose to read The Rise of Theodore Roosevelt during the first quarter of the year (it’s a big book, and a bully good one!). In Class 014, @florian started a book club specifically centered on self-improvement, and they’ve chosen to read The Productivity Project. Meanwhile in Class 017, @scooter started a book club that will first be reading The 7 Habits of Highly Effective People — another good one!

Picking up on Class 013’s idea of forming small accountability groups that we highlighted last time, several other Classes have formed their own accountability groups, often by using a shared Google doc for members to check in with each other. The way that Class 013 set up the groups was to give each one a separate thread in the Training Log forum. Numerous options can work.

Keep on living strenuously, everyone.

“The man who has not got great tasks to do cannot achieve greatness. Greatness only comes because the task to be done is great. The men who lead lives of mere ease, of mere pleasure, the men who go through life seeking how to avoid trouble, to avoid risk, to avoid effort, to them it is not given to achieve greatness. Greatness comes only to those who seek not how to avoid obstacles, but how to overcome them.” –Theodore Roosevelt.

The post A Peek at What’s Been Going on at The Strenuous Life appeared first on The Art of Manliness.

For women who haven’t yet had their first cervical smear test, the idea can be daunting and even a little scary. Here, we look at what having a smear test is really like. It’s not usually a hot topic for conversation and the idea of having the procedure leaves most women feeling clammy and nervous. The truth is, you’d be hard pressed to find anyone who looks forward to undressing in front of a relative stranger to have a physical examination.

However, worrying about having the test (or worse, avoiding it) pales into insignificance when you think about the health implications of not having a smear test.

Cervical screening saves 5,000 lives every year. Having regular cervical screening gives you the best protection against developing cervical cancer1.

What Is A Smear Test?

A smear test takes just three minutes. You will be asked to undress from the waist down and lie on a bed with legs bent, ankles together and knees apart. A speculum is inserted into the vagina and cells collected from around the cervix. These cells are sent to the lab for investigation. Between 90-94% of test results come back negative. Around one in twenty will come back ‘abnormal’, but this does not mean you have cancer. Some abnormal results indicate low grade changes which often return to normal of their own accord. However, further investigation of an abnormal result is standard2.

As with everything sexual health related, unfortunately myths and tall tales proliferate, often providing people with a ‘good’ reason not to do something. Dr Eskander, Consultant Gynaecologist at The Gynae Centre, dispels some of the myths around smear tests:

MYTH: Having a smear test is a long process

“No. The test itself takes just three minutes! However nervous you may feel at the outset, it’s good to remember that it will be over quicker than the time it takes to make a cup of tea.”

MYTH: Having a smear test is painful

“Having a smear test might be a little uncomfortable, often made more so by being nervous, but it should not be painful. If your smear test is very painful, this could indicate another underlying health issue such as thrush. Often it is easier and less painful if your health care provider uses lubricant, so if this is not done as a matter of course, you can ask for it to be used.”

MYTH: Cervical cancer is a young woman’s disease

“Actually, cervical smear incidence statistics show that there are two peak age ranges. The first in those aged 25-29, and then again in females aged 85-89. Half of deaths occur in women aged over 653.”

MYTH: I’ve been through the menopause and don’t need to continue having smear tests

“Going through the menopause does not prevent your risk of developing cervical cancer.”

MYTH: The test is designed to detect cancer

“Actually, the smear test is not designed to detect cancer but to look for cervical abnormalities. Not all abnormal cell results will lead to cancer. However, it’s important to remember that early detection and treatment of abnormal cells can prevent up to 75% of cervical cancer cases developing4.”

MYTH: Smear tests aren’t that reliable

“This is not true. Regular smear testing (every three years for women aged 25-49, and every five years for women aged 50-65) will give you a high degree of protection against developing cervical cancer.”

What’s Having A Smear Test Really Like?

Although avoiding smear test might sound like less hassle and one less thing to do in our busy lives, you are putting yourself at risk if you do not have regular testing. Ok, it’s not an ideal way to spend a morning/afternoon, and yes, all of us are nervous at the thought, but it’s quick and effective. The discomfort is minimal and lasts no time at all and there are plenty of tips that can make it a less awkward experience.

  • Choose a health care provider that you trust.
  • If you are nervous, tell your doctor/nurse. They have experience of dealing with nervous patients and of carrying out the procedure.
  • Your healthcare provider should offer you something to cover your modesty whilst going through the procedure. If they don’t then ask.
  • If you don’t feel comfortable doing it on your own, you can take someone with you.
  • If you would prefer a female practitioner, ask for one.
  • Try not to have vaginal intercourse or use creams or pessaries in that area for one to two days beforehand. These ‘can’ interfere with the result.
  • Try to be as relaxed as possible. The procedure will be easier and quicker if you are not pent up.

If you’ve had a smear test before, you know what to expect. If it is your first test then the sensation is a little strange and having a vaginal investigation always feels awkward, no matter how many times you’ve had one.

We are so health conscious on many levels today, so why do so many women avoid this vital exam? After all, you wouldn’t continue smoking and eat nothing but fried food if you wanted to live a long and healthy life. So, why avoid a test that ensures your health and wellbeing long term? Having a smear test is nothing to worry about. Not having a smear test might leave you at risk. That’s far more worrying!

Book a smear test with one of our trusted consultant gynaecologists at The Gynae Centre by calling us on 020 7580 8090.

Earning FDA approval for your drug program is a journey. A misstep at any point of that journey could jeopardize your chance at getting your drug approved. That’s why it’s so important to have a dependable roadmap that will get you where you want to go.

A misconception many sponsors have is that the FDA is a consulting organization to the pharmaceutical industry. Those sponsors think the Agency will provide them with a roadmap to approval. They couldn’t be more wrong.

In reality, the FDA is a science-based regulatory agency, operating with the expectation that each sponsor will come with a well thought out and justifiable plan that supports the safety and efficacy of their product. With a roadmap like this in place, the product has a healthy chance of getting approved.

What the Agency doesn’t want is for sponsors to be on a fishing expedition during meetings, hoping that the Agency will identify problems with their program and provide solutions. The FDA’s role is to protect the American consumer, not to guide sponsors through the drug development process.

Don’t Expect the FDA to Point Out Problems with Your Program

Some sponsors assume that, because the FDA didn’t raise an issue with their program during a meeting, they are pursuing the right path to obtaining approval. This is an assumption that should never be made. The Agency’s silence on an issue doesn’t mean that everything is okay. Things may be far from okay.

It’s up to the sponsor to think through their program, understand where the weak spots are, and decide what they are going to do about those weak spots. Contrary to what some sponsors may believe, the FDA has no obligation to point out problems within their program.

It’s not the Agency’s job to perform a gap analysis of the sponsor’s drug development program. It is also not their obligation to ensure that a sponsor’s program is successfully approved. Sponsors should not put themselves in the position of relying on the Agency to be the chief development officer of their program.

For sponsors, drawing an effective roadmap involves more than just identifying weak spots in their development program. During meetings, sponsors shouldn’t be afraid to address those weak spots head on, in a frank and open manner.

Because the objective is to get a clear understanding of the Agency’s position on matters relating to the drug being developed, it is crucial to ask questions that can be answered with a “yes” or a “no.” Binary questions such as “Do the Agency agree?” or “Is this acceptable?” are most likely to yield a response from the FDA that will be most helpful to drawing or revising a roadmap, and then following that roadmap to approval.

FDA Guidance Documents are Not a Roadmap

It’s true that sometimes the FDA provides guidance on the development of drug products. This guidance is typically a short document that may recommend the type of studies that should be conducted and the analytics to measure.

Take, for example, a pain medication product. Having approved many applications for pain medications, the FDA knows exactly what sponsors need to do to get their pain medication approved. Because this is such a well-beaten path, the Agency can communicate precisely what data the sponsor needs to provide. This guidance only expresses the Agency’s thinking on the topic at the time of publication. Therefore, it is not a roadmap. Among other things, the sponsor still has the responsibility of putting data into the appropriate context of what purpose the data is intended to serve.

However, for lesser understood conditions such as autism spectrum disorder, the roadmap to approval is untested. That’s because autism, a disorder consisting of a group of conditions and symptoms, has not been as relatively studied and characterized. In this case, there is no published guidance on the topic. It is entirely up to the sponsor to draw their own roadmap.

Drawing Your Own Roadmap

Successful sponsors understand that the FDA is a science-based, data-driven organization. This means that sponsors must draw a roadmap that enables them to provide the Agency with the data necessary to get approval. Essentially, the Agency is conducting a benefit analysis when deciding whether to approve a drug. When this analysis is complete, there must be more checks in the “benefit” column than the “risk” column.

While you can’t get your roadmap to approval from the FDA, The Weinberg Group can help you establish your own. Our services help you escape the echo chamber of your organization by providing you with an independent, third-party view of your program.

We’ve organized our company as a drug development unit. This means we have all the major disciplines in place to take a holistic, 360-degree perspective on your program. So, we are able to speak scientist to scientist regarding every aspect of your program.

Getting approval from the FDA is a moving target. Because we interact with the Agency on such a regular basis, we have a finger on the pulse of what the Agency’s thoughts are. This is important because the Agency is not a static organization. It is influenced by such things as the latest health crisis and the priorities of the current FDA commissioner.

Let us use our knowledge, experience, and positioning to help you draw your successful roadmap to approval.

The post Finding a Roadmap to Approval – Hint: You Can’t Pick One Up at the FDA appeared first on Weinberg Group.

With the holidays a month behind us, we’re going through the inventory at the Art of Manliness Store and clearing things out to make room for new products in 2018. Here are the latest items to be added to the AoM Clearance section:

40% Off All Grooming Products

Back in 2013 we introduced a line of Art of Manliness shaving gear: a safety razor, a badger brush, a lather mug, even a classy straight razor. For several years, the shaving stuff was some of our biggest sellers, but in the past year or so, interest in old-school shaving seems to have waned. It might have to do with the fact that once you buy a safety razor or a straight razor, you really don’t need to buy another one. You’re set for the rest of your life. Heck, I still use my grandpa’s 60-year-old Gillette safety razor and my great-grandpa’s 100-year-old straight razor. With that in mind, we’re retiring our AoM shaving gear. 

If you’re a last hold-out and haven’t set yourself up for life yet with a safety or straight razor, you’re in luck. We’ve marked down all the shaving stuff 40%. Once it’s gone, it’s gone for good. Get one of these razors before it’s too late. It’ll be a collector’s item one day worth hundreds of dollars on Antiques Roadshow.

40% Off the 2018 Illustrated Calendar

Learn a new skill each month with our 2018 Illustrated Guide Desk Calendar. Each month you’ll find one of our famous, one-of-a-kind illustrations by Ted Slampyak showing you how to master a variety of skills from surviving hypothermia to carving a turkey like a man.

We’ve got a few of these left in stock and since we’re already a month into the new year, we’ve put them on sale for 40% off. Grab one today and become a handier man the rest of the year through.

The post AoM Store Clearance: 40% Off All Grooming Products and 2018 Calendar appeared first on The Art of Manliness.

No one has an ugly baby.

At least, no one thinks their baby is ugly. Every new parent thinks their baby is the most beautiful baby of all time. The unfortunate fact is that there are ugly babies. We’ve all been in the position of looking at someone’s baby and biting our tongue because we know that their baby isn’t as beautiful as they think it is.

And that’s appropriate.  Because niceties need to exist when talk about a real baby.  Such tact isn’t useful when discussing drug development.

Your baby is your drug. If your development program is ugly, even just a little bit, brutal honesty from your advisors is necessary.  Your regulatory consultant should never bite their tongue. They should tell you what needs to be, and they should do so early and often.

Sure, the truth hurts. But, hearing the truth and figuring out what to do about it can save you time and money, and possibly lots of both.

The Pressure to Succeed Can Create an Echo Chamber

Time and money are always top priorities for sponsors.

This pressure on a drug development program to succeed sometimes causes the sponsor to minimize important factors and data during the development process. This stance can lead to wasted effort, the wrong path and lost opportunities to succeed.

For instance, in an effort to shave time off their study, a sponsor might decide to submit their IND with only six months of stability data. They are doing this with full knowledge that, according to FDA guidance, sponsors are required to submit 12 months of stability data.

The top-down pressure to succeed from within the organization may make the sponsor decide that waiting another six months is too long. In their own echo chamber, they’ve convinced themselves that they have an acceptable product that they will present to the FDA, and that the FDA will allow it to proceed, or even approve it. The developers may hold onto this belief despite knowledge to the contrary, talking themselves into believing what they want. In other words, they have an ugly baby and they have no one there to tell them otherwise.

That’s what a good regulatory consultant can do for you. A great regulatory consultant will not only tell you that your baby is ugly, but will also tell you what you can do about it.

It’s Always Time to Hear the Truth About Your Baby

Sponsors need to hear the truth about their drug development program as early as possible. They also need to hear the truth as frequently as possible throughout the development continuum. That’s because knowing the truth can save time and money.

Hearing the truth early in the process helps the sponsor make any necessary changes to their program. Depending on what is wrong with the program, they can work with their regulatory consultant to fix the problem and guide the program towards a trajectory that has a higher probability of success when presented to the FDA.

Hearing the truth late in the process can create nightmares. The program may be so off-course that getting it back on-track may mean spending more time and millions of dollars in order to do things like change protocols, change the program’s design, or conduct more, longer, or bigger studies.

Furthermore, the program may have already gotten so ugly that there is no way to salvage it. As such, if a program needs to be terminated, it should happen as early as possible. The more time that passes, the more money has been spent, and the drug asset becomes more valuable. Late in the game is not the time to hear the truth; especially if the truth results in the loss of a once-valuable asset.

How Beautiful is Your Baby?

To many sponsors, their baby is beautiful and utterly flawless, even though there is evidence to the contrary. Our job is to come in and perform an objective analysis from an external party that may result in us telling them that their baby isn’t so beautiful after all. But our work doesn’t stop there. It is also our job to explain the reasons why the sponsor’s baby isn’t flawless so that they can make the changes necessary to get their baby approved by the FDA.

Fortunately, we do get to tell sponsors that their baby is objectively beautiful. One of the ways that we provide added value is when we can reassure sponsors that they are on the right path and should expect positive outcomes at the FDA.

Contact us today to learn more about our services and how we can help your drug development program succeed.

The post The Truth Can Hurt – But Hearing It at the Right Time Can Save Time and Money appeared first on Weinberg Group.

For most women with Uterine Fibroids, cancer is not an issue because fibroids are essentially benign growths in the uterus that can be removed or shrunk. However, in extremely rare cases, instead of a non-cancerous growth, women may be dealing with a type of cancer known as a uterine sarcoma. Unfortunately for these women, there is no definite way of knowing prior to surgery if the tumor is benign or cancerous.

When undergoing a hysterectomy or myomectomy through the laparoscope, a device known as a morcellator breaks up tissue into tiny pieces that can then be removed through a small incision. After surgery, study of the tissue can indicate if cancerous cells are present. When the morcellator cuts tissue to extract it, small pieces of a cancerous growth have the potential to spread.

Due to growing concern, the FDA investigated the correlation between women diagnosed with uterine sarcoma and those who have received this procedure. Through public hearings with gynecologists and manufacturers of the morcellators, the FDA has asked for further studies and for gynecologists to discuss with their patients the small possible risk involved with the use of morcellators before proceeding with surgery.

While the spread of cancer may make women want to second-guess getting treatment for fibroids, the worst thing to do is put it off. At the Fibroid Treatment Collective, we can help treat women with an alternative option for their fibroids. Embolization, a non-surgical fibroids treatment in Los Angeles, has helped women around the world achieve a fibroid-free life.

Unlike a hysterectomy or myomectomy, which surgically remove the uterus or fibroids, fibroid embolization keeps the uterus completely intact, and shrinks fibroids by removing their blood supply. In the rare case embolization fails, our team will know within a two-week period and help our patients find the cause, which may be a uterine sarcoma. To learn more about how non-surgical fibroids treatment in Los Angeles can be the right choice for you, or more about the use of laparoscopic power morcellators, get in touch with us at (888)296-9422.

The post Can Invasive Fibroid Surgery Risk Spreading Cancer? appeared first on Treatment for Uterine Fibroids with Embolization (UFE).

Add Some Quality Sleep To Improve Your Diet Not sleeping well can lead to a number of problems and unfortunately, many adults often get less sleep than they need—lesser than the generally recommended eight hours of sleep a night. Recent study conducted by the King's College London suggests that increased sleep can be a clear-cut technique to help pare sugar [...]

The post Curb The Carb and Sugar Cravings With A Sleep Diet appeared first on Medshape Weight Loss Clinics.

Hey, did you know there’s an Art of Manliness app for iPhone and Android devices?

It’s true, and we’ve recently updated the app based on user feedback. Here’s what’s new with the Art of Manliness app:

Better Offline Reading. Have you ever been in a place with no wifi and had the itch to read some AoM? With our recent update to the app, this is no longer a problem. The app caches the most recent articles on your phone so if you find yourself disconnected from the internet (or just don’t want to waste mobile data), you can still read the latest AoM content.

Cleaner and Easier to Use. We’ve updated the layout for easier reading and navigation. 

Ad-Free Option. The app is free thanks to a small ad placed at the bottom of the app. While not super intrusive, we did get requests from several users to provide an option to pay to remove the ad. So we did. For $1.99 a month, you can remove the ad. It’s all done through an in-app purchase via the App Store or Google Play. You can manage your subscription in the app menu in the upper-left hand corner, and you can easily cancel at anytime.

Of course, if you don’t want to pay, you can still read the content for free on the app with the ad or on the site in your browser. 

More Updates to Come

We’ll continue to update the app. The next feature we’d like to add is the ability to save favorite articles. 

Download the Art of Manliness App!


A Thank You to Our All-Star Readers

Your smartphone screen is primo real estate, so for you to download our app is a real honor for us. Thanks in advance to all our “AoM All-Star Readers” who decide to download our app and make the Art of Manliness a more integral part of their daily lives. We’ll continue to do our best to send you content via the app that’s geared towards helping you become a better man in all aspects of your life.

The post Download the Updated Art of Manliness App appeared first on The Art of Manliness.

Want To Eat Healthy When Dining Out? Going out to eat can always be a tricky situation when you're trying to stick to healthier eating habits. People tend to avoid restaurants when they’re watching their weight and agrees that a lower-calorie meal option when dining away from home is the best way to keep their food-related goals. So to help you stick to your healthy [...]

The post Stay On With Your Diet With These Best Arizona Healthy Dining Restaurants appeared first on Medshape Weight Loss Clinics.

For the majority of a woman’s reproductive life, the regularity of her menstrual cycle is closely associated to her well-being, while an irregular menstruation can often be a sign of abnormal activity in the body. In some instances, Uterine Fibroids are the cause of these abnormalities. For more information on the types of fibroids and steps you can take towards effective fibroid treatment, contact the top fibroids specialist in Los Angeles, Dr. Bruce McLucas for a consultation.

The three types of fibroids: intramural, subserosal, and submucosal can produce different symptoms based on the size and location of the fibroids. Intramural and submucosal fibroids are usually the cause of heavy or abnormal bleeding during a menstrual cycle.

While the main reason for these symptoms are unknown, abnormal bleeding is believed to be caused by the way fibroids change the muscular contraction of the uterus which can prevent it from controlling the amount of bleeding during a cycle. Fibroids have also been shown to compress veins in the uterine wall, creating a dilation of the uterine lining. As the pressure increases in the veins, the lining of the uterus expands, and may result in abnormal bleeding. Heavy menstrual bleeding is usually caused by either intramural fibroids found deep within the wall of the uterus, or submucosal fibroids, found just under the inner lining of the uterus.

Heavy and abnormal bleeding not only increases clot formation, but can also prolong periods, lead to weakness, fatigue, painful cramps in the abdomen and back, and in some cases anemia. Women who have experienced heavy or difficult periods may often not consider fibroids a viable reason for the irregularity in their cycle. If you undergo any of these abnormal symptoms or suffer from overnight excessive flow, consistent bleeding through super tampons or maxi pads, consider making an appointment with your ob/gyn to see if fibroids may be the cause.

Fibroids Specialist in Los Angeles

If fibroids are the cause of your heavy or painful menstrual cycle, don’t delay in seeking effective treatment from a qualified fibroids specialist in Los Angeles. Uterine Fibroid Embolization is a non-surgical procedure especially suited for today’s active, and busy lifestyle. It’s also a great alternative treatment for younger women who may wish to have children because it protects fertility by not cutting, removing, or scarring any uterine tissue. For more information on how embolization can put an end to irregular menstruation, contact The Fibroid Treatment Collective at (888) 296-9422.

The post How Fibroids Affect the Menstrual Cycle appeared first on Treatment for Uterine Fibroids with Embolization (UFE).

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Zion Clinic Pharmacy
205 E. Hallandale Beach Blvd
Hallandale Beach, Fl 33009

Phone 954-367-5365
Fax       954-839-9039

Zion Health Store




Zion Clinic Pharmacy complies with all the requirements of the Ryan Haight Online Pharmacy Act. Zion Clinic Pharmacy will only dispense a controlled substance to a person who has a valid prescription from a Florida licensed physician issued for a legitimate medical purpose based on a medical relationship with a prescribing practitioner. This includes at least one prior in-person medical evaluation in accordance with applicable requirements of section 309 of the Controlled Substances Act (21 U.S.C. 829). Zion Clinic Pharmacy will not fill any prescription based on an online questionnaire alone.


The contents of this website are intended for informational use only. It is not intended to or designed to provide medical advice, professional diagnosis, treatment services or to replace your physician’s medical care. Information about the drug products contained on the website does not cover all possible uses, actions, precautions, side effects or interactions. Please consult your medical doctor before making any decisions concerning your health. All medications are compounded in a licensed compounding facility under the direct supervision of licensed pharmacist using FDA approved ingredients and in compliance with Florida State Board of Pharmacy regulations. All products are dispensed for individual patient use pursuant to a patient-specific prescription from a licensed physician.