On September 29, 2023, the U.S. Food and Drug Administration (FDA or "agency") announced the opportunity for a limited number of sponsors to participate in a new pilot program called Support for clinical Trials Advancing Rare...more
Speaking at the World Stem Cell Summit hosted by the Regenerative Medicine Foundation last week, Hogan Lovells partners Mike Druckman, Stuart Langbein, and Thomas Beimers discussed evolving government reimbursement issues for...more
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
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
The U.S. Food and Drug Administration (FDA) extended the enforcement discretion period for certain human cell, tissue, and cellular and tissue-based products (HCT/Ps) by an additional six months, citing the challenges...more
7/21/2020
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