FDA releases the FDA-483 with four observations from an inspection at Chandler, AZ-based Tailstorm Health, an outsourcing facility.
FDA issues a new guidance with recommendations on using Covid-19 convalescent plasma under either an emergency use authorization or IND during the pub...
FDA and Polynoma reach agreement under a Special Protocol Assessment on a pivotal Phase 3 clinical trial of the companys melanoma cancer vaccine sevip...
FDA has approved a Cochlear Limited PMA for its Cochlear Nucleus Implants for treating unilateral hearing loss and single-sided deafness.
FDA acting commissioner Janet Woodcock tells a Senate Health, Education, Labor & Pensions hearing that the current omicron variants effects on the hea...
FDA approves an Idorsia Pharmaceuticals NDA for Quviviq (daridorexant) 25 mg and 50 mg for treating adult patients with insomnia.
Federal Register notice: FDA sends to OMB an information collection revision entitled Drug Supply Chain Security Act Implementation (OMB Control Numbe...
FDA posts a draft guidance entitled Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the...