The FDA has selected seven rare disease therapies to participate in its Support for clinical Trials Advancing Rare disease Therapeutics (START) Pilot Program to accelerate the development of novel drug…

Understanding what documents you must provide to the FDA during an inspection — and what’s off limits to the agency — is a key to timely and effective responses, according…

CDER, as part of its Emerging Drug Safety Technology Program (EDSTP) will hold meetings for drug makers and others to discuss their research, development, and use of AI and other…

As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws…

This edition of Quick Notes offers news on medical devices including two continuous glucose monitoring system clearances for Abbott, cybersecurity vulnerabilities for Baxter Welch Allyn, clearance of an AI solution…

Nearly two years after the FDA approved hearing aids to be sold OTC without involvement of a licensed professional, a Government Accountability Office (GAO) study found that barriers to treatment…

Recalled products from Medtronic and Megadyne have been deemed Class I by the FDA — Medtronic for a potential software issue and Megadyne for the potential for burn injuries during…

Eli Lilly will make a case for its antiamyloid antibody donanemab on June 10, trying to reassure the Peripheral and Central Nervous System Advisory Committee that the drug is safe,…

This week, the FDA issued two draft guidances on Bioresearch Monitoring Inspections (BIMO). Source: Drug Industry Daily

Drug-induced liver disease observed in a phase 1/2 clinical trial of Biomea Fusion’s BMF-219 (covalent menin inhibitor) in type 1 and type 2 diabetes has resulted in the FDA requesting…