FDA’s CBER vows crackdown on unapproved stem, cell therapies

FDA will end a period of “compliance and enforcement discretion” that has given manufacturers of human cell, tissue, and cellular and tissue-based products time to submit marketing applications. The discretion, which was slated to end in November 2020 and was extended as a result of challenges posed by COVID-19, will end May 31, Peter Marks, director of FDA’s Center for Biologics Evaluation and Research (CBER), announced in a blog post.

Marks stated that FDA has worked since November 2016 with “product developers to help them determine if they need to submit an IND or marketing application and, if so, how they should submit their application.” ...