The current COVID-19 emergency has made it difficult for drugs and biologics manufacturers and sponsors to achieve their timelines for research and development of new products. Considering this, the USFDA has extended the enforcement discretion policy for certain investigational new drug applications . The United States Food and Drug Administration (USFDA) has recently extended the enforcement discretion policy for certain human cells, tissues, and cellular and tissue-based products (HCT/Ps).
The decision was made based on the challenges presented by the COVID-19 pandemic. According to the policy, manufacturers and sponsors of HCT/Ps will be provided an additional six months to plan and prepare for an Investigational New Drug (IND) or a marketing application. The FDA has also informed that the discretion will be exercised until November 2020 for certain regenerative products.…
