December 21, 2019 at 02:07AM Regenerative Medicine Update: Information for Industry on FDA’s Compliance and Enforcement Policy Regarding Certain Regulatory Requirements December 2018

The guidance on minimal manipulation/homologous use, issued in November 2017 (and corrected in December 2017), included information on the agency's compliance and enforcement policy regarding HCT/Ps. The FDA is now reminding industry that the enforcement discretion period ends in Nov 2020.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/2rkkLye