Flexible Tracheostomy Tube Recall: Medtronic Removes Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula Due to Risk for Disconnection of the Flange from the Device Cannula

CGMP/Finished Pharmaceuticals/Adulterated

Medline is recalling certain Convenience Kits due to being labeled as sterile but not having gone through the sterilization process

In accordance with the Generic Drug User Fee Amendments (GDUFA), FDA consults with industry and the public to create an annual list of regulatory science initiatives on generic drugs. These priorities are discussed and developed in public meetings and workshops, resulting in several awarded projects

The Role of Pharmacodynamic Biomarkers in Biosimilar Drug Development