Medical Device and Pharmaceutical News
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FDA Streamlines Biosimilar Development to Reduce Drug Costs
FDA Moves to Streamline Biosimilar Development and Reduce Drug Costs The U.S. Food and Drug Administration (FDA) has announced new steps to simplify the development pathway for biosimilar medicines, a move intended to reduce development costs and improve patient...
FDA Inspections for Domestic and Foreign Device Manufacturers
Early Observations: Comparing FDA Inspection OutcomesStriking Difference in Inspection Outcomes for Domestic and Foreign Device Manufacturers One of the most revealing early insights from our analysis of FDA inspection data emerges when the results are separated...
A Leap in FDA Transparency – The Electronic FOIA Reading Room
Exploring FDA’s FOIA Electronic Reading RoomA New Window into Inspection Findings The U.S. Food and Drug Administration (FDA) has expanded public access to regulatory information through its FOIA Electronic Reading Room, making large datasets from inspections and...
Tippy Toes Apple Pear Banana Baby Food Recalled
Baby Food Recalled for Elevated Patulin Levels Recall Date: February 13, 2026Company: IF Copack LLC d.b.a. Initiative FoodsBrand: Tippy ToesProduct Type: Baby Food Fruit PuréeHazard: Elevated levels of patulin (a mycotoxin) Initiative Foods has issued a voluntary...
FDA Program to Accelerate U.S. Pharmaceutical Manufacturing
FDA Launches “PreCheck” Pilot Program to Accelerate U.S. Pharmaceutical Manufacturing The U.S. Food and Drug Administration has launched a new pilot initiative aimed at strengthening domestic pharmaceutical manufacturing and improving regulatory predictability for...
FDA Approves Novel Device for Pancreatic Cancer Treatment
FDA Approves Novel Device for Pancreatic Cancer Treatment The U.S. Food and Drug Administration has approved Optune Pax, a first-of-its-kind medical device designed to treat adult patients with locally advanced pancreatic cancer. Developed by Novocure, the portable...
When Apparel Becomes a Medical Device
Lessons from FDA’s Breast Binder Warning Letters In December 2025, the FDA issued warning letters to several companies selling breast binders and chest compression garments online. The agency concluded that marketing claims on company websites, like statements about...
FDA Issues 30 Warning Letters to Telehealth Firms
FDA Issues 30 Warning Letters to Telehealth Firms Over Compounded GLP-1 Marketing Claims On March 3, 2026, the U.S. Food and Drug Administration (FDA) announced that it has issued 30 warning letters to telehealth companies for making false or misleading claims...
FDA Warning Letter Cites Key CGMP and Data Integrity Failures
FDA Warning Letter Highlights Fundamental CGMP and Data Integrity Failures The FDA has issued a Warning Letter to A. Nelson & Co. Ltd. citing significant violations of Current Good Manufacturing Practice (CGMP) requirements under 21 CFR Parts 210 and 211 at a...
Implications of the New Federal Vaccine Schedule for Children
The New Federal Vaccine Schedule for Children: What Changed and What Are the Implications?Authors: Jennifer Kates and Josh Michaud, KFF This story was originally published by KFF.As widely expected, and following a recent Presidential memorandum, the Department of...