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Dawah Quarterly Newsletter and Industry News


 

Industry News

FDA is Advancing New Efforts to Address Drug Shortages By: Scott Gottlieb, M.D., FDA Commissioner and Janet Woodcock, M.D., Director of FDA’s Center for Drug Evaluation and Research


A key component of our public health mission is to help ensure Americans have access to safe and effective medicines. That’s why, as drug shortages arise, we take immediate action within our authorities, working across the FDA and with other government agencies, industry, and other stakeholders, to minimize the impact of these shortages and maintain or restore availability of critical medicines for the patients who need them.

A shortage of even one critical drug can have a significant effect on U.S. patients‘ health. So many of our efforts are focused on preventing shortages in the first place. But when shortages arise, we must also focus on identifying the root cause, and on taking steps to help make sure similar circumstances don’t happen again. The lessons we learn help us inform and improve our efforts to prevent shortages in the future.


Ensuring that a necessary drug is available to a patient involves a lot of stakeholders working together at key stages of the development, manufacturing, marketing, and distribution of a medicine. This collaboration and coordination also applies when we work together to curtail a shortage.


Yet, despite our extensive efforts to prevent these shortages, they continue to occur and persist for a myriad of reasons. To more directly address these important public health challenges, the FDA developed a comprehensive three-pronged approach that focuses on preventing shortages, early identification of anticipated shortages, and responding by remedying the underlying problems when shortages arise to the extent possible within our current authorities.


This approach will be discussed as part of a much larger conversation later this month, when we will host a public meeting (https://healthpolicy.duke.edu/events/drug-shortage-task-force)  (http://www.fda.gov/about-fda/website-policies/website-disclaimer) to bring together stakeholders for an interactive, collaborative discussion to further inform our efforts and build on this work to identify strategies and solutions for minimizing harm from shortages.


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What the FDA Does to Address Drug Shortages

  • Drug Shortage Staff focused on addressing drug shortages

  • Facilitate temporary and long term strategies to address shortages

  • Coordinate timely and comprehensive risk/benefit decisions within FDA

  • Personnel across multiple FDA Offices involved in shortage response

  • Distribute information (web posting, professional organizations):

  • https://www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm

  • Goal: Maintain availability while minimizing risk to patients


 

Dawah Pharmaceuticals Inc. is no longer a startup. With three drugs entering the FDA approval process we will be to market with Drug 1 by 2Q2020 and Drug2/3 by 4Q2020.

Now is the time to invest, as our financial team and CFO have determined that our price per share will increase significantly once our first drug reaches the market.

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