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Regulatory Standards Center for Biologics Evaluation and Research (CBER)

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q1 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Hogan Lovells

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

Hogan Lovells on

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

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