Category Archives: FDA Policy

FDA’s Strategic Policy Roadmap – Part 2 Addressing Addiction

With deaths rising each year, there is no question of the urgency that something needs to be done to address the opioid misuse epidemic in the United States. And in addition to mortality there are the lives touched by these … Continue reading

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FDA’s 2018 Strategic Policy Roadmap, Part 1

In January, FDA’s Commissioner announced the release of “Health Innovation, Safer Families: FDA’s 2018 Strategic Policy Roadmap” that provides a detailed overview of priorities for the agency within a relatively short timeframe. FDA and the various centers that make up … Continue reading

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Taking a Peek at Transparency – An FDA Pilot Program

Yesterday, Commissioner Scott Gottlieb announced a new effort on the part of the agency aimed at increasing transparency around clinical trials, a goal long sought by many patient advocates, particularly outside the U.S.  Specifically, FDA is introducing a pilot program … Continue reading

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Biggest FDA Developments for 2017

As we begin the new year, it is time toassess the previous year and consider what really mattered when all is said and done. We’ve perhaps already done this on a personal level, but here is my take on an … Continue reading

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Is FDA Set for Another Banner Year of Approvals?

In 2015, FDA experienced a banner year with respect to the number of novel drugs and biologics that were approved by the agency – 45 all told. Since then, the 21st Century Cures Act was passed with the goal, among … Continue reading

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