Delivery Method: VIA UPS Reference #: 320-26-46 Product: Drugs Recipient: Recipient Name Michael Lockett Recipient Title Chief Executive Officer A. Nelson & Co. Ltd. 83 Parkside London SW19 5LP United Kingdom Issuing Office: Center for Drug Evaluation …
Delivery Method: VIA UPS Reference #: 320-26-45 Product: Drugs Recipient: Recipient Name Mr. Marc N. Ross Recipient Title Quality Manager/Co-Owner AQ USA Inc., d.b.a Ross Healthcare Inc. 210 S Duffner Dr., Suite A Lynden, WA 98264 United States Issuing …
Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Daniel D. Hernandez Recipient Title Director of Quality MedisourceRx 10525 Humbolt Street Los Alamitos, CA 90720-5401 United States Issuing Office: Center for Drug Evaluation and …
Docket Number: FDA-2026-D-1256 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research The purpose of this guidance is to describe considerations for generating substantial evidence of …
For Immediate Release: February 23, 2026 The U.S. Food and Drug Administration today issued draft guidance for sponsors seeking approval for targeted individualized therapies by generating substantial evidence of effectiveness and safety when randomized …
COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …
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 Generic Drugs Forum is a two-day event designed to facilitate the development and approval of …
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.) for adults with chronic lymphocytic leukemia (CLL) or …
Delivery Method: Via Email Product: Biologics Recipient: Recipient Name Jon Tavarez Recipient Title Founder & Chief Executive Officer Germaphobix 6950 E Adamo Dr Tampa, FL 33619 United States info@germaphobix.com Issuing Office: Center for Biologics …
Delivery Method: Via Email Product: Biologics Medical Devices Recipient: Recipient Name Bruce R. Werber, DPM Recipient Title Chief Executive Officer and Founder BioXtek LLC 316 NE 1st St Pompano Beach, FL 33060 United States docw@bioxtek.com Issuing Office …
Delivery Method: Via Email Product: Biologics Recipient: Recipient Name Martin D. Bastuba, M.D. Recipient Title Owner/Medical Director Sperm Bank, Inc. dba Fertility Center of California 6699 Alvarado Road, Suite 2208 San Diego, CA 92120 United States …
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 Corporate Drive, Suite 2 Portsmouth, NH 03801 United States Issuing Office: …
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 October 21, 2021. Graduation is the process through which ETP …
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COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …
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 Manufacturers Pty Ltd. PO Box 5767 Queensland Mail Centre Bundall QLD …
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 and Research, LLC 110 Corporate Drive, Suite 2 Portsmouth, NH …
COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …
COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement Summary Company …
COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …
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