GW Pharmaceuticals submits a supplemental NDA for Epidiolex (cannabidiol) oral solution for an expanded use to include seizures associated with Tubero...
A DC federal judge sides with FDA in a Vanda Pharmaceuticals lawsuit that sought to remove a partial clinical hold the agency imposed prohibiting Vand...
FDA Review posts the Federal Register notices for the week ending 1/31/2020.
Federal Register notice: FDA makes available a final guidance on testing retroviral vector-based human gene therapy products.
Federal Register notice: FDA makes available a final guidance entitled Long Term Follow-Up After Administration of Human Gene Therapy Products.
FDA issues a Warning Letter to Smart Toothpicks (Tempe, AZ) after the agency determined that its dissolvable tobacco products, Peppermint Ice Nicotine...
Federal Register notice: FDA makes available a draft guidance on recommendations to reduce the possible risk of transmission of Creutzfeldt-Jakob Dise...