An FDA town hall gives a detailed explanation of the new medical device Quality Management System Regulation and answers frequently asked questions ab...
The Contraceptive Study Group submits a second petition to FDA seeking changes in labeling for hormonally active contraceptives to reflect all of the ...
FDA warns Philadelphia, PA-based Medical Products Laboratories about CGMP violations in its manufacturing of unapproved new drugs.
FDA warns Livonia, MI-based Purolea Cosmetics Lab about CGMP and other violations in its production of finished drugs as a contractor.
Medical device regulation expert Adrienne Lentz describes the highlights from a 4/2 FDA Quality Management System Regulation town hall.
FDA posts a draft guidance outlining how drug developers should evaluate the safety of human gene therapies that use genome editing.
Exelixis petitions FDA to require Handa Pharmaceuticals and others submitting a 505(b)(2) NDA for a caboztinib product referencing Exelixis Cabometyx ...
Three McDermott attorneys outline the key elements in an FDA 3/2026 guidance that helps establishments respond to an FDA-483.
