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OPDP eCTD

by | Sep 9, 2025 | News

On June 24, 2019, FDA issued a final guidance for industry entitled Providing Regulatory Submissions in Electronic and Non-Electronic Format–Promotional Labeling and Advertising Materials for Human Prescription Drugs. This guidance finalizes the draft guidance...

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...