Recently cleared IVD devices, including Antimicrobial Susceptibility Test (AST) devices, include: February 15, 2024: The FDA cleared the PBC [positive blood culture] Separator with Selux Antimicrobial Susceptibility […]

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Ms. Belkisa Grbic Recipient Title General Manager Makra Kozmetika D.O.O. Kolodvorska Cesta 24000 KranjSlovenia Issuing Office: Center […]

Product: Drugs Recipient: Recipient Name Christopher Ingram Supercore Products Group, Inc. 230 Peachtree Street Ste 2200Atlanta, GA 30303United States [email protected] Issuing Office: Center for Drug Evaluation […]

Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Mr. William Richard Wilson Recipient Title Director of Operations Little Moon Essentials, LLC 501 Old Griffin […]

Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Mr. Asim Ozcan Recipient Title President Clean Solutions LLC 791 Paulison Ave., Suite 5Clifton, NJ 07011-3608United […]

Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Mr. Harold I. Diamond Recipient Title President Diamond Chemical Co., Inc. Union Avenue & Dubois StreetEast […]

Docket Number: FDA-2017-D-1105 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Office of the Commissioner, Office of […]

As part of the Accelerating Rare disease Cures (ARC) Program, CDER’s Rare Diseases Team (RDT) inaugurated the Learning and Education to Advance and Empower Rare Disease […]

On This Page Date: November 21, 2024 Time: 1:00 PM – 3:00 PM ET AGENDA Visit CDER Small Business and Industry Assistance Page ABOUT THIS EVENT […]