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Center for Biologics Evaluation and Research (CBER) Food and Drug Administration (FDA) Grace Period

Hogan Lovells

Unapproved stem cell therapies remains a top FDA enforcement priority

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Speaking Tuesday at the Food and Drug Law Institute (FDLI) Annual Conference, Mark Raza, FDA Chief Counsel, discussed the investigations priorities for FDA’s Office of the Chief Counsel (OCC), including its focus on stopping...more

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Time’s really up! FDA authority to crack down on regenerative medicines upheld as grace period ends

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On July 9, 2021, the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) added a Q&A page on its website about the May 31 end of the grace period intended to provide developers of human...more

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