The Contraceptive Study Group submits a second petition to FDA seeking changes in labeling for hormonally active contraceptives to reflect all of the ...
FDA extends until 11/22 its review of a Savara BLA for molgramostim to treat autoimmune pulmonary alveolar proteinosis.
The Trump Administration looks to move FDA principal deputy commissioner Sarah Brenner to a senior leadership role at the CDC.
FDA issues an updated compliance program that standardizes how inspectors evaluate manufacturing facilities tied to biologic drug applications.
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FDA posts a draft guidance outlining how drug developers should evaluate the safety of human gene therapies that use genome editing.
