FDA Review posts the Federal Register notices for the week ending 4/5/2019
Federal Register notice: FDA makes available a final guidance entitled Risk Evaluation and Mitigation Strategy: FDAs Application of Statutory Factors ...
Federal Register notice: FDA determines that Monarch Pharmaceuticals Cortisporin (hydrocortisone/neomycin sulfate/polymyxin B sulfate) was not withdra...
Federal Register notice: FDA determines that Tevas Qvar 40 and Qvar 80 (beclomethasone dipropionate HFA) inhalation aerosol products were not withdraw...
Celgene submits a BLA for luspatercept, an erythroid maturation agent for treating adult patients with very low to intermediate risk myelodysplastic s...
Jazz Pharmaceuticals, Lundbeck, and Alexion Pharmaceuticals agree to pay a total of $122.6 million to resolve allegations that they each violated the ...
FDA posts a 24-page Form 483 from a 5/2018 inspection of Akorns Decatur, IL sterile drug manufacturing operation.
The Alliance for a Stronger FDA advocates for a 15% ($60 million) increase to President Trumps FY 2020 budget proposal that would boost funding by $41...