With Trump review, a Harvard infectious disease researcher stands to lose it all (STAT)
Unique pain research office eliminated in HHS purge (STAT)
RFK Jr. says he plans to tell CDC to stop recommending fluoride in drinking water (STAT)
Trump’s US FDA Takeover Similar To Flat Earth Proponents Running NASA, Woodcock Says (Pink Sheet)
US FDA Center Directors Are Political Now (Pink Sheet)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.
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Following months of negotiations with industry, the US Food and Drug Administration (FDA) has published its proposed commitment letter for the Generic Drug User Fee Amendments (GDUFA IV) program.
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has released a revised guide for inspectors and the pharmaceutical industry outlining the general principles of qualification and validation studies in pharmaceutical manufacturing facilities.