The National Cancer Institute helps launch the Pragmatica-Lung Study as part of an effort with FDA to modernize clinical trials.
FDA warns Totowa, NJ-based Omega Packaging Corp. about CGMP violations in its production of drugs as a contract facility.
A JAMA Network Open study from the University of Missouri-Kansas City finds a relationship between Class 3 medical device supplements and device recal...
Vanda Pharmaceuticals asks FDA to revoke its approval of a Teva ANDA for a generic form of Vandas sleep drug Hetlioz and recall the product.
FDA publishes two updated draft guidances with current information on aspects of drug transdermal and topical delivery systems to promote the developm...
In two appellate briefs, plaintiffs and defendants argue over jurisdiction issues in their legal fight involving the abortion drug mifepristone (Mifep...
An FDA safety alert warns against the use of certain surgical N95 respirators manufactured by O&M Halyard due to protection failures.
FDA clears an Avation Medical 510(k) for Vivally, a bladder control therapy device and mobile application for treating patients with urinary urgency a...
