The Prescription Drug User Fee Act of 1992 (PDUFA), Biosimilar User Fee Act of 2012 (BsUFA), and Generic Drug User Fee Amendments of 2012 (GDUFA) authorize […]

On September 25, 2025, the Food and Drug Administration approved imlunestrant (Inluriyo, Eli Lilly and Company), an estrogen receptor antagonist, for adults with estrogen receptor (ER)-positive, […]

Reference #: FEI 1025483 Product: Drugs Recipient: Recipient Name Mr. Adalberto R. Cabrera Recipient Title Chief Operating Officer Tarmac Products, Inc. 16311 NW 52nd AVEMiami Gardens, […]

Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Adalberto Cabrera Recipient Title Chief Operating Officer Tarmac Products, Inc. 16311 NW 52nd AvenueMiami Gardens, FL […]

About OTC Monograph Reform On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) (Public Law No. 116-136, 134 Stat. 281, 457) […]

OTC MONOGRAPHS @ FDA A resource for the public to view OTC Monographs and their Administrative Orders (Proposed, Final, and Interim Final). OTC Monographs@FDA also facilitates […]

One of the areas FDA is committed to enhancing and modernizing is the FDA drug safety system, in part through the optimization of the Sentinel Initiative. […]

Delivery Method: VIA EMAIL WITH READ RECEIPT Reference #: 320-25-110 Product: Drugs Over-the-Counter Drugs Recipient: Recipient Name Mr. Gilad Wielunski Media Networks Sydney Pty. Limited 36 […]

[9-23-2025] The Food and Drug Administration is advising consumers not to purchase or use Flexi Bion, a product promoted and sold for joint pain on various […]