FDA Establishes Q&A Page Following End of HCT/P Enforcement Discretion Policy

July 14, 2021

The Food and Drug Administration established a web page to answer questions from manufacturers of human cells, tissues, and cellular and tissue-based products (HCT/Ps) following the end of the agency’s enforcement discretion period, which concluded May 31. The web page provides the agency’s current thinking on its approach to compliance and enforcement, requirements for product marketing and administration, disclosure policy for investigational new drug (IND) applications, and other IND-related topics. HCT/P manufacturers who are unsure of how FDA will regulate their product should review the July 2020 guidance on regulatory considerations HCT/Ps.