Learn from the Source: These presentations deliver perspectives directly from CDER subject matter experts who shape the policies and procedures that impact your product development and […]

Under the Prescription Drug User Fee Act (PDUFA) VII Commitment Letter[1], FDA is creating the Split Real Time Application Review (STAR) pilot program.   Overview FDA […]

On this page: Program Description In October 2022, under the Prescription Drug User Fee Act reauthorization (PDUFA VII), FDA launched the Split Real Time Application Review […]

Delivery Method: Via Email Reference #: 320-26-36 Product: Drugs Recipient: Recipient Name Steven F. Pressman Recipient Title CEO Winder Laboratories, LLC 716 Patrick Industrial LaneWinder, GA […]

Delivery Method: Via Email Reference #: 320-26-34 Product: Drugs Recipient: Recipient Name Mr. Rushabh Vora Recipient Title Managing Director Chemspec Chemicals Private Limited Plot 3-C, Taluka […]

Delivery Method: VIA UNITED PARCEL SERVICE AND VIA E-MAIL Reference #: 25-HFD-45-12-03 Product: Drugs Recipient: Purushothaman Damodara Kumaran, M.D. Senthil Specialty Hospital Number 10 and 12, […]

The labeling of GLP-1 RA medications approved for weight reduction in persons with obesity or overweight contains information in the Warnings and Precautions section regarding a […]

What are “Novel” Drugs? “Novel” drugs are new drugs never before approved or marketed in the U.S. See Drugs@FDA for information about all of CDER’s approved […]

For Immediate Release: January 12, 2026 The U.S. Food and Drug Administration today approved the Zycubo (copper histidinate) injection as the first treatment for Menkes disease […]