The FDA reaffirmed the timing of the end of the compliance and enforcement discretion policy for certain human cell, tissue, and cellular and tissue-based products (HCT/Ps), including regenerative medicine therapies. The period during which the FDA intends to exercise enforcement discretion with respect to the investigational new drug (IND) and premarket approval requirements for certain HCT/Ps ends on May 31, 2021 and will not be extended further.
This compliance and enforcement discretion policy gives manufacturers time to determine if certain requirements apply to their products, and if an application is needed, to prepare and submit the appropriate application to the FDA.
Read more at the U.S. Food and Drug Administration >>