Staff in the FDA Oncology Center of Excellence say ways must be found to improve studies leading to accelerated approval to shorten the time in which ...
FDAs Oncologic Drugs Advisory Committee votes 9-4 against recommending accelerated approval for Spectrum Pharmaceuticals Pozenveo (poziotinib) and its...
Former U.S. Attorney Gregory Brower discusses four takeaways from a recent Department of Justice memo on increased corporate enforcement actions.
FDA posts a draft guidance entitled How to Obtain a Covered Product Authorization for generic drug developers having trouble getting samples for devel...
Federal Register notice: FDA determines that GlaxoSmithKlines prescription-only NIX (permethrin) 1% topical creme rinse was not withdrawn from sale fo...
FDA releases a form FDA-483 with five observations from an inspection at the Cipla drug manufacturing facility in Goa, India.
FDA concurs with six recommendations made by the HHS Inspector General to improve the EUA process for tests in a future pandemic.
FDA approves Fennec Pharmaceuticals Pedmark to treat cisplatin-associated ototoxicity in pediatric patients.
