On August 18, 2017, the President signed into law the Food and Drug Administration Reauthorization Act (FDARA). This new law includes the reauthorization of the Prescription […]

Save the Date Agenda Coming Soon Register Here Visit CDER Small Business and Industry Assistance (SBIA) Homepage About this Event (Hosted by CDER SBIA) The annual […]

On February 19, 2026, the Food and Drug Administration approved acalabrutinib (Calquence, AstraZeneca) tablets and capsules in combination with venetoclax (Venclexta, AbbVie Inc. and Genentech Inc.) […]

Emerging Technology Program Graduates its First Technology The Emerging Technology Program (ETP) is proud to announce it graduated its first technology, Continuous Direct Compression (CDC) on […]

Delivery Method: VIA UNITED PARCEL SERVICE AND VIA E-MAIL Reference #: 26-HFD-45-02-02 Product: Drugs Recipient: Recipient Name Bertrand P. Cole, D.O. Bertrand P. Cole, D.O. 110 […]

Delivery Method: VIA UNITED PARCEL SERVICE AND VIA E-MAIL Reference #: 26-HFD-45-02-02 Product: Drugs Recipient: Recipient Name Bertrand P. Cole, D.O. Bertrand P. Cole, D.O./Activmed Practices […]

Delivery Method: VIA EMAIL WITH READ RECEIPT Reference #: 320-26-43 Product: Drugs Recipient: Recipient Name Mr. Valentine P. Fittler Recipient Title CEO & Managing Director Cosmetic […]

Delivery Method: Via Overnight Delivery Product: DrugsFood & Beverages Issuing Office: Center for Food Safety and Applied Nutrition (CFSAN) United States WARNING LETTER July 1, 2022 […]

[2-13-2026] The Food and Drug Administration is advising consumers not to purchase or use Boner Bears Chocolate, a product promoted and sold for sexual enhancement on […]