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Time’s up: New enforcement era for regenerative medicines begins June 1 - CBER reiterates May 31 end for HCT/P compliance “grace...

On April 21, 2021, FDA’s Center for Biologics Evaluation and Research (CBER) Director Peter Marks M.D. confirmed that the grace period intended to provide developers of regenerative medicines with time to assess whether they...more

HHS now requires public posting of a decade of clinical trial results that were previously exempted

Earlier this year, we wrote about a ruling by the U.S. District Court for the Southern District of New York that, if upheld, would require companies to make public a decade of clinical trial results for products that have...more

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