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Office of Prescription Drug Promotion

by | Sep 9, 2025 | News

The Office of Prescription Drug Promotion (OPDP)’s work is supported by social science research. This research program was designed to investigate applied and theoretical issues of relevance to direct-to-consumer (DTC) and healthcare provider-directed promotional...

Shirish M. Gadgeel, M.D. – 716181

by | Sep 9, 2025 | News

Delivery Method: VIA UNITED PARCEL SERVICE AND VIA E-MAIL Reference #: 25-HFD-45-09-01 Product: Drugs Recipient: Shirish M. Gadgeel, M.D. 2799 West Grand BoulevardDetroit, MI 48202-2608United States Issuing Office: Center for Drug Evaluation and Research (CDER) United...

Hikal Limited – 709370 – 08/20/2025

by | Sep 9, 2025 | News

Delivery Method: Via Email Reference #: 320-25-102 Product: Drugs Recipient: Recipient Name Dr. K Suresh Babu Recipient Title Head – Corporate Quality and Regulatory Affairs Hikal Limited 72 – 82 / A Kiadb Industrial AreaJigani 560105KarnatakaIndia Issuing...

Biosimilars Guidances

by | Sep 8, 2025 | News

Should you find a Web link (URL) embedded within guidance documents that does not work or other documents posted on the FDA Web site, please try searching for the document using the document title. If you need further assistance, please go to Contact...

Safety Labeling Change Orders

by | Sep 8, 2025 | News

3/14/2025ANDA-070765, ANDA-070766Chlordiazepoxide and Amitriptyline HydrochlorideANDA REPOSITORY, LLCArchive4/28/2023NDA-019758Clozaril (Clozapine)HERITAGE LIFE SCIENCES BARBADOS INCArchive9/20/2021NDA-018936Prozac (Fluoxetine Hydrochloride)ELI LILLY AND...

Guidance for Industry

by | Sep 8, 2025 | News

Docket Number: FDA-2023-D-1955 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research The Food and Drug Administration is announcing the availability of a final guidance for industry entitled “E6(R3)...

Middlefield Original Cheese Co-Op Recalls Organic Gouda, Colored Cheddar, Mozzarella/Provolone, Pepper Jack, Swiss, Dilly Pickle Cheese and Monterey Jack Due to Possible Listeria Monocytogenes Contamination

by | Sep 8, 2025 | News

Summary Company Announcement Date: September 05, 2025 FDA Publish Date: September 08, 2025 Product Type: Food & Beverages Cheese/Cheese Product Foodborne Illness Reason for Announcement: Recall Reason Description Potential contamination with-Listeria...