FDA classifies a correction involving certain ventilators manufactured by Philips as a Class I recall, warning that continued use of the devices witho...
FDA seeks expansion of testosterone replacement therapy use, encouraging drugmakers to explore whether existing products could be approved to treat lo...
CDER issues two revised Manuals of Policies and Procedures relating to developing and communicating postmarketing requirements and commitments.
FDA plans a 7/23-24 Pharmacy Compounding Advisory Committee meeting to discuss adding certain peptides to the agencys bulk drugs for compounding list....
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 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.
