New instructions to remove TactiFlex Ablation Catheter from package

by Pill Pals Customer Service | Sep 18, 2025 | News

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk issue. The FDA will keep the public informed and update this web page as significant new information becomes...

Safety Labeling Changes—Section 505(o)(4) of the FD&C Act

by Pill Pals Customer Service | Sep 18, 2025 | News

Docket Number: FDA-2011-D-0164 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry...

Generic Drug Development: Translating Science to Approval

by Pill Pals Customer Service | Sep 17, 2025 | News

Advancing Generic Drug Development: Translating Science to Approval Keynote Address Janet Woodcock, MDActing Commissioner of Food and DrugsFood and Drug Administration COVID-19 Impact on Generic Drug Regulation and EvaluationProtecting Participants in Bioequivalence...

Modeling and Artificial Intelligence (AI) in Generic Drugs Workshop

by Pill Pals Customer Service | Sep 17, 2025 | News

On This Page Date: October 15 – 16, 2025 Day1: Wed, Oct 15 8:30 a.m. – 05:00 p.m. ET Day2: Thu, Oct 16 8:30 a.m. – 03:40 p.m. ET Location: Event Location The Universities at Shady Grove Building II9630 Gudelsky DriveRockville, MD 20850United States...

Withdrawn Expired Guidances

by Pill Pals Customer Service | Sep 17, 2025 | News

Cancer Drug and Biological Products – Clinical Data in Marketing Applications10/12/200109/17/2025 Oncologic Drug Advisory Committee Discussion on FDA Requirements for Approval of New Drugs for Treatment of Colon and Rectal Cancers04/19/198809/17/2025 FDA...