Federal Register notice: FDA seeks comments on an information collection revision to Additional Criteria and Procedures for Classifying Over- the-Coun...
FDAs Los Angeles District Office warns B. Braun Medical about repeat CGMP violations at its Irvine, CA, drug manufacturing facility.
FDAs Los Angeles District Office warns Med-Pharmex about CGMP violations in its production of animal drugs.
Belcher Pharmaceuticals petitions FDA to revise its epinephrine product sulfite warning to acknowledge that the companys sulfite-free epinephrine inje...
Officials of FDA and its European and Japanese counterparts agree to work toward harmonizing clinical study requirements for antibacterial agents for ...
FDA Review posts Federal Register notices for the week ending 5/26/2017.
The House Energy and Commerce Committee asks for additional information from NIH to verify corrections and the resolution of clinical research complia...
FDA accepts for priority review a Kite Pharma BLA for axicabtagene ciloleucel for treating non-Hodgkin lymphoma.