CDER Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality (CDER Quality Standards Program)

FDA has determined that a REMS is no longer necessary to ensure ERA medicines’ benefits outweigh the risk of EFT.

Interstate Commerce/Food/Adulterated

Learn how to spot health fraud and avoid it.

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

Abbreviated New Drug Applications and following the path to generic drug approval. Generic drug applications are termed “abbreviated” because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, generic applicants

Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection