[ Price : $8.95]
FDA extends until 11/22 its review of a Savara BLA for molgramostim to treat autoimmune pulmonary alveolar proteinosis.[ Price : $8.95]
The Trump Administration looks to move FDA principal deputy commissioner Sarah Brenner to a senior leadership role at the CDC.[ Price : $8.95]
FDA issues an updated compliance program that standardizes how inspectors evaluate manufacturing facilities tied to biologic drug ...[ Price : $8.95]
CDER issues two revised Manuals of Policies and Procedures relating to developing and communicating postmarketing requirements and...[ Price : $8.95]
FDA plans a 7/23-24 Pharmacy Compounding Advisory Committee meeting to discuss adding certain peptides to the agencys bulk drugs f...[ Price : $8.95]
FDA warns Philadelphia, PA-based Medical Products Laboratories about CGMP violations in its manufacturing of unapproved new drugs.[ Price : $8.95]
FDA warns Livonia, MI-based Purolea Cosmetics Lab about CGMP and other violations in its production of finished drugs as a contrac...[ Price : $8.95]
Medical device regulation expert Adrienne Lentz describes the highlights from a 4/2 FDA Quality Management System Regulation town ...