FDA Mulls ‘Intermediate Pathway’ For Certain Cell Therapy Products

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...