Category Archives: FDA Policy

What They Said in 2016 – FDA Releases

FDA ended the year quietly and began the new year in similar fashion. The holidays are of course a factor, but in all of October and November of 2016, there were only 3 releases issued for each month. Even in … Continue reading

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New Directions for FDA, Part 2 – Regulatory Matters

In Part 1 about change facing FDA, we looked at the 21st Century Cures Act and some of the change that would be in store for FDA. But in this post-election cycle, there is more than pending legislation that could … Continue reading

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New Directions for FDA, Part 1 – 21st Century Cures

One of the often stated priorities for lame-duck Congress has been voting on the 21st Century Cures Act. In a press release from Saturday, November 26 from the House Energy and Commerce Committee, the House is set to vote on … Continue reading

Posted in Current Affairs, FDA Policy, Legislation | 1 Comment

FDA Seeking Even More Input on Character Space Limitation

This week FDA published a notice in the Federal Register seeking comment on the proposed collection of information regarding research entitled “Character-Space-Limited Online Prescription Drug Communications“. The notice states that the objective of the research is to test whether a … Continue reading

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Breakthrough Therapy Status, AdComms and Approvals

In recent years FDA has undertaken several means to facilitate the consideration of new drug applications by creating various mechanisms for expedited review for either new drugs or new indications for existing drugs. Prior to 2012, there had long been … Continue reading

Posted in Advisory Committee Prepapartion, FDA Policy | 1 Comment