Regulatory Uncategorized

Revising ANDA Labeling Following Revision of the RLD Labeling

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled “Revising abbreviated new drug applications (ANDAs) Labeling Following Revision of the reference listed drugs (RLDs).” In this guidance, FDA is providing information on How ANDA applicants and holders should monitor for changes to RLD labeling: The sponsor […]

Regulatory

Cross Labeling Oncology Drugs in Combination Regimens Draft Guidance Issued by FDA

Cross labeling guidance is in response to increasing requests from sponsors applying for oncology drugs intended to be used in combination regimens. The purpose of this guidance is to describe FDA’s current recommendations about including relevant information in labeling for oncology drugs approved for use in a combination regimen, including important considerations for cross labeling […]