FDA Launches Crackdown on Deceptive Drug Advertising

by Pill Pals Customer Service | Sep 9, 2025 | News

For Immediate Release: September 09, 2025 The U.S. Department of Health and Human Services and the Food and Drug Administration today announced sweeping reforms to rein in misleading direct-to-consumer pharmaceutical advertisements. Today, the FDA is sending thousands...

FDA approves gemcitabine intravesical system

by Pill Pals Customer Service | Sep 9, 2025 | News

On September 9, 2025, the Food and Drug Administration approved gemcitabine intravesical system (Inlexzo, Janssen Biotech, Inc.) for adults with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or...

OPDP eCTD

by Pill Pals Customer Service | 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 This guidance finalizes the draft guidance...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 Pill Pals Customer Service | 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 Pill Pals Customer Service | 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 Pill Pals Customer Service | 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...