FDA Taking “Risk-Based Approach” To Sequestration Cuts
This article was originally published in The Tan Sheet
The agency will try to manage $319 million in potential funding reductions in a way that minimizes negative effects on health and safety, Commissioner Hamburg tells the Science Board, but significant layoffs seem unavoidable if sequestration is enacted.
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FDA and advocates wait to see how an estimated 7.8% budget cut would be implemented, if enacted. Former agency officials say sequestration could lead to hiring freezes and program delays.
Advisory committee says planned waivers for molecularly targeted studies should take into account comparative adult efficacy and toxicity data for multiple drugs in the same class, as well as differences in product attributes, such as route of administration and dosing schedule; unmet clinical need should have less influence on decision to grant waivers, panelists said.
The use of various acronyms – including RRA, RIE and RRR – to describe remote assessments of sites and study data has been confusing and makes it sound as though people are speaking ‘like a pirate,’ Office of Study Integrity and Surveillance director Sean Kassim says.