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Category: Blog

Part one of four-part active travel series.

The post Active Travel Series: Valencia, Spain — Part One of Four appeared first on Healthy Aging ®.

Can One Keep Up With A Low Calorie Diet In an eagerness to lose weight,  a lot of people would find themselves trying different diets. However, there is a huge difference between someone who claims to be "on a diet" as oppose to those who are "having a diet".  People "on a diet" becomes too [...]

The post Restrictive Eating Through Low Calorie Diet appeared first on Medshape Weight Loss Clinics.

Too many women packs on excessive pounds during pregnancy. Matter of fact, you help your baby grow and provide nourishment to the developing fetus by adding in a few pounds during pregnancy.  However, the weight you gain during pregnancy should remain at a steady pace. While it is okay to work out when you’re pregnant (as [...]

The post Losing Weight During Pregnancy: Do It Safely appeared first on Medshape Weight Loss Clinics.

With fall’s cooler weather coming, t-shirts are starting to get swapped for long-sleeved apparel. To welcome the cooler temperatures and to prepare for new items in the store, we’re having a huge t-shirt sale at the Art of Manliness Store.

All t-shirts are 40% off!

Our shirts usually sell for $21.99. At 40% off, you’re looking at $13.20 for a shirt. Tis a bargain sweeter than a hot mug of apple cider.

Stock up on AoM tees while you can. When some of these tee designs are gone, they’ll be gone for good.

Sale ends October 23, 2017.

The post Huge Fall T-Shirt Sale! 40% Off All Tees appeared first on The Art of Manliness.

Warning! This Extreme Diet Approach May Not Suit Everyone Would you eat just one meal a day? A Harvard and Oxford University-educated doctor stresses the weight loss benefits and convenience of this extreme diet plan, but warns the approach may not suit everyone. Fasting of any kind is thought to place a 'gentle stress' on the body, [...]

The post Harvard University Doctor Advocates A One Meal A Day Diet That Can Work appeared first on Medshape Weight Loss Clinics.

Like many other women, there is a good chance that you are concerned with your appearance. In general, women are much more concerned about their looks than men are. The key reason for this is that their appearance is crucial to how they are judged by others. Most of women's dissatisfaction focus around weight issues, namely, [...]

The post Weight Loss Programs For Women: It’s Not Just About Physical Change appeared first on Medshape Weight Loss Clinics.

It's been dubbed a 'gastric band in a glass' - but the latest weight loss food sweeping the showbiz world is far from appetizing. The Amorphophallus konjac - or Devil's Tongue - has been hailed as the new wonder ingredient for dieters thanks to its slimming properties. But slimmers beware - its distinctive odor has been compared to [...]

The post This New Weight Loss Food Is Sweeping The Showbiz World But Far From Appealing appeared first on Medshape Weight Loss Clinics.

Easy apple tart recipe

The post Fall is For Apple Picking, Tail Gating and Getting Back into the Kitchen appeared first on Healthy Aging ®.

Losing weight may not be so easy. But by taking after the right strategy, it can be effortless. Studies propose that anyone can get in shape even without diet or adhere oneself to a customary exercise plan. Yes it is conceivable. The truth is, there are viable ways that can enable you to slim down [...]

The post Achieve Weight Loss Without Dieting appeared first on Medshape Weight Loss Clinics.

On the occasion of BugBitten's fourth birthday: time to reflect

Super Healthy Foods You Must Eat This Fall A lot of us may not know that foods have a season. With the fall season upon us, we are even more reminded of the value of eating healthy foods with the seasons. These foods in season contain the nutrients, minerals and trace elements that our bodies [...]

The post Maximize Your Nutrition With These Healthy Foods In Season This Fall appeared first on Medshape Weight Loss Clinics.

Coffee and Tea Can Extend A Diabetic Woman's Lifespan The wonders and health benefits of coffee are varied. Your morning cup has been thought to lower risks of certain diseases like Parkinson’s and diabetes, in addition to boosting metabolism. Now, a new study indicates that drinking coffee could also keep you living longer—if you’re a diabetic woman. Scientists in [...]

The post Health Benefits of Coffee Include Longer Life For Diabetics, New Study Shows appeared first on Medshape Weight Loss Clinics.

Get Body-Confident With The Right Weight Loss Program in Minnesota If you are truly committed to losing weight, the decision to work with weight loss clinics will be among the best personal decisions you can make. You need to make sure that the Minnesota professional you choose to work with is qualified and experienced. However, with [...]

The post Weight Loss Programs MN: Succeed In Your Journey To A Healthy Lifestyle appeared first on Medshape Weight Loss Clinics.

The Food and Drug Administration has laid out a drug development continuum that includes three milestones, or Type B meetings. Earliest is the Pre-IND Meeting, the second is the End of Phase 2 (EOP2) Meeting, and the third milestone is the Pre-NDA Meeting.

Each meeting has a different agenda. This is because each meeting occurs at a different point in the development continuum. Nevertheless, all of the meetings share the same ultimate goal, which is to gain clarity in order to be able to proceed successfully to the next step in the development process.

There’s quite a bit of preparation involved with planning and carrying out a successful meeting with the FDA. It starts with determining what questions to ask. It’s important that you are not afraid to ask certain questions just because you don’t want to get negative answers to those questions. Getting a firm “no” after you’ve submitted the NDA hurts a lot more than getting that “no” earlier in the process.

Whether the feedback is positive or negative in nature, attending each of these meetings take away the unknown. If the feedback is positive, that’s a good thing. If the feedback is negative, that’s also a good thing. This is because the sponsor is now able to deal with the issue(s) that received negative feedback before the next submission or meeting.

The Pre-IND Meeting

The Pre-IND Meeting marks your first formal interaction with the FDA. In this meeting, you are introducing your product concept as well as a general plan outlining how you intend to turn that concept into reality. The overarching purpose of this meeting is to get in front of the FDA so that you can validate your clinical development program before you begin work.

As with each of the meetings, it is up to the sponsor to set the agenda for the meeting. Although the FDA has a standard meeting “template” that is designed to gain essential information, the sponsor decides which questions to ask. Consequently, the discussions that take place in this meeting are extremely strategic in nature.

Each question should be formulated so that you will receive a “yes” or “no” answer to a question that is important to the development process. The questions should be presented in paragraph format, providing context and statements, and ending with the question, “Does the agency agree?”

How do you know if you’ve had a successful meeting? You’ll know you’ve had a successful meeting when you’ve received the guidance you are looking for. You may not have received the answers you wanted, but what you should be focused on is whether you received the clarity you need in order to proceed.

End of Phase 2 Meeting

With a typical program, the End of Phase 2 Meeting will take place several years after the Pre-IND Meeting. By now, you will have conducted clinical trials, so in this meeting, you are presenting clinical data to the FDA in pursuit of enrolling into your Phase 3 pivotal trials. Think of this part of the discussion as providing proof of concept that your product works. Your goal is to get the FDA’s agreement that you have proven your concept and that the product shows promise.

You will present your Phase 3 program to the FDA during this meeting, which outlines the clinical trials that you plan to conduct. Your goal in this part of the meeting is to ask the question: “If we conduct these trials and the data are positive, will this warrant submission and approval of our NDA?” Again, you’re looking for “Yes” or “No” answers because Phase 3 of any clinical program can cost tens to hundreds of millions of dollars. As such, you want to make sure that you plan to do what the FDA wants you to do, making it crucial that you get clarity on all aspects of the planned trials.

Pre-NDA Meeting

The Pre-NDA Meeting (or in the biologic space, the Pre-BLA Meeting) is the meeting where you are presenting your entire package of data to the FDA in a meeting setting. You’ve done all of the work. You’ve had multiple formal and informal interactions with the FDA. Now, during this meeting, by summarizing how many trials you completed and the outcomes of those trials, you are presenting a high-level view of what you have accomplished.

At this point, your goal is to get confirmation from the FDA that you have a data package that warrants submission of an NDA (or BLA). In essence, you want their agreement to this fact. Their positive response is a way of saying that they don’t see anything that rises to the level that clearly indicates that your NDA is not ready to be submitted.

Get Your Meetings Correct

It is crucial that you take advantage of the opportunities that you have to engage with the FDA. Ultimately, conducting the three milestone meetings are in the best interests of getting your program approved. The Weinberg Group understands how to navigate the underlying strategic objectives of each meeting and can assist you in gaining the clarity you need to successfully move along the drug development continuum.

The post How to Prepare for the Three Type B Meetings with the FDA appeared first on Weinberg Group.

  This September marks the 6th annual global World Alzheimer’s Month. This year is following the theme “Remember Me” and emphasizes the importance of early detection and diagnosis of dementia.   The Nothern Virginia area will be hosting several walks throughout the month to raise awareness of Alzheimer’s and dementia in communities. Integrated Neurology Services […]

The post Join us for World Alzheimer’s Month appeared first on .


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