Researchers question Gottlieb ties, balk against NIH cuts

A new survey of U.S. scientists, FDA researchers and biomedical clinicians has found that most are concerned over FDA Commissioner nominee Scott Gottlieb’s long list of ties to biopharmas, with the majority also believing that proposed cuts to the National Institutes of Health (NIH) would hurt drug discovery.

Failure to Reauthorize User Fee Programs Would Result in About 3,000 FDA Layoffs

Representatives from the biotechnology, medical device and generic drug industries told members of the Senate Committee on Health, Education, Labor & Pensions on Tuesday, April 4, 2017 that if the five-year user fee programs are not reauthorized, the US Food and Drug Administration (FDA) would likely see more than 3,000 job cuts.

FDA Office of Regulatory Affairs Realignment to Begin in May

The US Food and Drug Administration’s (FDA) Office of Regulatory Affairs (ORA), which carries out the agency’s inspection program, will officially begin a major overhaul in the coming weeks, according to FDA’s Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren.