FDA warns 14 companies about marketing more than 65 products claiming to have anti-cancer properties.
FDA publishes a draft guidance on criteria and the process for government stakeholders to seek an extension to the expiration date for doxycycline sto...
Federal Register notice: CDER announces its continuation of the Regulatory Project Management Site Tours and Regulatory Interaction program.
Federal Register notice: FDA withdraws approval of two NDAs held by Guerbet Group after being notified that the products were no longer marketed.
FDA clears an Allergan 510(k) for TrueTear Intranasal Tear Neurostimulator, a handheld device developed to temporarily increase tear production during...
FDA releases its latest batch of Warning Letters that includes Divis Laboratories, Exact-Rx and Teva Pharmaceutical and Chemical.
Lonza receives an FDA Warning Letter after an inspection at the firms Walkersville, MD bioscience solutions manufacturing plant.
Federal Register notice: FDA announces a 5/17 e Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee meeting where pan...