FY 2024 GDUFA Science and Research Report

 FDA’s generic drug Science and Research Program, created under the Generic Drug User Fee Amendments (GDUFA), is an essential component of FDA’s mission to protect and promote public health. The Science and Research Program is implemented through extensive research...

Guidances & Reports

The research studies conducted under the Generic Drug User Fee Amendments (GDUFA) initiatives support development of general and product-specific guidances for industry to efficiently develop new generic products. FDA’s Office of Generic Drugs also publishes an...

Brassica Pharma Pvt. Ltd. – 679005

Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Mr. Uday Chile Brassica Pharma Pvt. Ltd. 301, Soni Palace, Haridas NagarNear Hero Honda ShowroomBorivali (West) 400092India Issuing Office: Center for Drug Evaluation and Research (CDER)...

V10Suppliers.com – 685496 – 07/22/2024

Recipient: V10Suppliers.com United Kingdom Issuing Office: Center for Drug Evaluation and Research (CDER) United States FROM: The United States Food and Drug Administration RE: Notice of Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over...