FDA posts a guidance on Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (Covid-19) Pub...
Federal Register notice: FDA amends its animal drug regulations to reflect recent application-related actions for new animal drug applications and abb...
FDA says it is pleased with an additional $80 million from the just-signed $2 trillion stimulus package that will fund some of its Covid-19 response e...
FDA posts a guidance on Notifying FDA about a medical product discontinuance or interruption in manufacturing.
FDA issues an updated guidance entitled Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic to add an appendix on common questions...
FDA approves a Zoll Medical PMA for the TherOx System, which provides supersaturated oxygen therapy to reduce heart muscle damage in certain heart att...
Battelle gains an emergency use authorization for its Critical Care Decontamination System for decontaminating respirator masks.
FDA approves an Eli Lilly supplemental BLA for Taltz (ixekizumab) injection, 80 mg/mL, for treating pediatric patients with moderate to severe plaque ...