[ Price : $8.95]
Staff in the FDA Oncology Center of Excellence say ways must be found to improve studies leading to accelerated approval to shorte...[ Price : $8.95]
FDAs Oncologic Drugs Advisory Committee votes 9-4 against recommending accelerated approval for Spectrum Pharmaceuticals Pozenveo ...[ Price : $8.95]
FDA clears a Medtronic 510(k) for its LINQ II Insertable Cardiac Monitor system for expanded use in pediatric patients over the ag...[ Price : $8.95]
Former U.S. Attorney Gregory Brower discusses four takeaways from a recent Department of Justice memo on increased corporate enfor...[ Price : $8.95]
FDA posts a draft guidance entitled How to Obtain a Covered Product Authorization for generic drug developers having trouble getti...[ Price : $8.95]
Federal Register notice: FDA determines that GlaxoSmithKlines prescription-only NIX (permethrin) 1% topical creme rinse was not wi...[ Price : $8.95]
FDA releases a form FDA-483 with five observations from an inspection at the Cipla drug manufacturing facility in Goa, India.[ Price : $8.95]
FDA concurs with six recommendations made by the HHS Inspector General to improve the EUA process for tests in a future pandemic.