Bulletin 20-12

FDA Extends Enforcement Discretion Policy for Certain HCT/Ps

July 20, 2020

Today, the FDA announced an update to its final guidance document to revise “section V of the November 2017 guidance to communicate that the Agency is extending the period of time during which FDA intends to exercise enforcement discretion regarding certain regulatory requirements for certain HCT/Ps; this time period will run through May 31, 2021, instead of November 30, 2020.”

The document further states:  “This will give manufacturers additional time to determine if they need to submit an investigational new drug (IND) or marketing application and, if such an application is needed, to prepare the IND or marketing application. Such additional time is warranted in light of the Coronavirus Disease 2019 (COVID-19) public health emergency, which has presented unique challenges in recruiting clinical trial participants and carrying out clinical trials.”

Click here to read the full announcement.