15/16 September 2020
The U.S. Food and Drug Administration FDA has published two new Question and Answer Documents on Investigational Drugs.
One of the draft Guidance for Industry documents is intended to provide information for industry, researchers, and physicians about the implementation of FDA's regulation on charging for investigational drugs under an Investigational New Drug Application (IND) (21 CFR 312.8). The other one is intended to provide information about the implementation of FDA's regulations on expanded access to investigational drugs for treatment use under an investigational new drug application (IND) (21 CFR part 312, subpart I).
Both documents are being distributed for comment purposes only.