FDA Mulls ‘Intermediate Pathway’ For Certain Cell Therapy Products

By Beth Wang / May 13, 2022 at 5:07 PM
FDA is exploring potential intermediate approval pathways for cell therapy products that fall between the agency’s human tissue regulations, which don’t require premarket authorization, and the more-stringent biologics license application pre-approval process, FDA biologics center chief Peter Marks recently said. Marks did not specify which types of cell therapy products might fall under such a pathway when he made his comments during a recent Alliance for a Stronger FDA webinar. Marks also would like to set up a pilot program...

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