Since the passage of the Biosimilar User Fee Act (BsUFA) in 2012, user fees have played an important role in expediting the process for the review […]

The Food and Drug Administration Amendments Act (FDAAA) requires that the FDA track and make publicly available certain pediatric information resulting from pediatric clinical trials pursuant […]

Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Devices and Radiological Health Center for Drug Evaluation and Research Center for Food […]

Delivery Method: VIA UPS Reference #: 320-24-33 Product: Drugs Recipient: Recipient Name Mr. Tae Woo Anh Recipient Title Chief Executive Officer C&T Dream Co., Ltd. 60 […]

Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Mr. Ricardo Cardona Recipient Title President Master Paints & Chemicals Corp. PMB 240, 425 Carr. 693 […]

Delivery Method: Via Email Reference #: 320-24-32 Product: Drugs Recipient: Recipient Name Mr. Rajeev Nannapaneni Recipient Title Vice Chairman and CEO Natco Pharma Limited Natco House […]

Assertio Therapeutics, Inc. Cambia (diclofenac potassium) powder for oral solution 9/28/22 12/7/22   Genus Lifesciences Inc. Tivorbex (indomethacin) capsules 9/29/22    No Response   Primus Pharmaceuticals […]

Guidance Snapshots are a communication tool that provide highlights from guidance documents using visuals and plain language to support transparent communication and dissemination of FDA guidance […]

Generic drugs are copies that one company makes of a brand-name drug that was developed by another company.  Generally, generic drugs sell at lower prices, and […]