FDA warns Woodstock, CT-based Linemaster Switch Corp. about Quality System violations in its production of medical device foot pedal accessories.
FDA warns Hiram, GA-based VasoCorp Inc. that it is illegally marketing misbranded unapproved new drugs.
The Pharmaceutical Research and Manufacturers of America urges FDA to revise and clarify its draft guidance on using quantitative systems pharmacology...
FDA issues a 26-page Form 483 to Alkem Laboratories following an 4/20-5/1 inspection of the company's finished drug manufacturing facility in Daman, I...
FDA posts 17 revised draft product-specific guidances for peptide products, which it touts as a significant advancement in the agencys scientific and ...
Novo Nordisk intensifies pressure against Eli Lilly under a motion seeking a preliminary injunction to stop Eli Lilly's misleading GLP-1 advertising c...
CBER recently used a virtual town hall to urge developers of cell and gene therapies to take advantage of early engagements with the agency well befor...
An FDA final guidance encourages sponsors of oncology clinical trials to broaden eligibility criteria by including more patients with reduced performa...
