The Patient Engagement Advisory Committee (PEAC) — FDA’s only advisory committee comprised solely of patients, caregivers, and patient advocates — is seeking guidance on improving access to home-use medical devices…

The FDA spells out the process for a generic drug facility to request a meeting to discuss deficiencies outlined in a warning letter, in a draft guidance released Friday. Source:…

After dropping its challenge to the proposed transaction last week, the FTC will allow Amgen’s $27.8 billion buyout of Horizon Therapeutics to proceed under terms set in a consent order…

The FDA’s Center for Drug Evaluation and Research (CDER) seeks to dispel “possible misconceptions” about its proposed quality management maturity (QMM) system in a new white paper. Source: Drug Industry…

Over the past week, the FDA issued guidance on its intention not to take action to enforce the requirements of DSCSA until Nov. 27, 2024, recommendations on system attributes necessary…

The FDA has deemed as class I another in a series of voluntary recalls from Getinge/Maquet/Datascope for various models of its Cardiosave Hybrid and Cardiosave Rescue intra-aortic balloon pump (IABP),…

AdvaMed and the Medical Device Manufacturers Association (MDMA) commented this week on a CMS notice expediting Medicare coverage of emerging technologies, urging swift acceptance of the program, but also arguing…

Sen. Elizabeth Warren (D-Mass.) and Rep. Pramila Jayapal (D-Wash.) want the FDA to close loopholes that keep generic drugs off the market, they said in a recent letter to FDA…

FDA’s expedited regulatory programs cut up to two years off both clinical development and approval times for more than half of the drugs approved from 2015-2022, according to a new…

The FDA has deemed Hamilton Medical’s recall of certain of its ventilators as class I, the most serious type of recall as use the device may lead to serious injury…