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.
The US agency is re-evaluating its criteria for certain human cells, tissues and cellular and tissue-based products (HCT/Ps) that are not ideally regulated as BLAs. A 2014 guidance on cord blood products could serve a template, industry suggests.
Agency re-evaluating criteria for certain human cells, tissues and cellular and tissue-based products (HCT/Ps) that are not ideally regulated as BLAs; industry suggests a 2014 guidance which created an alternative pathway for cord blood products could serve as potential template.