FDA posts an unusual internal memorandum detailing how former CDER acting director Tracy Beth Hoeg opposed approval of a Sanofi supplemental BLA for Tzield, only to have her position overturned after her departure from the agency.
Medical Devices
Data from First 100 QMSR Inspections Analyzed
Medical device expert Marcelo Trevino analyzes for Med Device Online the results from the first 100 FDA inspections under the new Quality Management System Regulation.
