Termination of the Food and Drug Administration's Unapproved Drugs Initiative; Request for Information Regarding Drugs Potentially Generally Recognized as Safe and Effective

摘要

The Department of Health and Human Services is issuing this Notice to withdraw FDA's Marketed Unapproved Drugs--Compliance Policy Guide, Sec. 440.100, Marketed New Drugs Without Approved NDAs or ANDAs, and to request information from the public regarding drugs that may be grandfathered or generally recognized as safe and effective.