A subset of products subject to the biologics transition process in March 2020 may continue using drug master file information after they become biologics license applications, even though the US Food and Drug Administration currently prevents the practice.
US FDA Will Allow Transitioning Products To Continue Referencing Drug Master Files
The 'technical detail' needed to be resolved in part to ensure there would be no shortages after the 2020 change from regulation as drugs to biologics for certain protein products, the agency said.
