FDA and the Duke-Margolis Center for Health Policy publish a summary of a 2019 workshop they co-sponsored on improving the communication of drug inter...
Federal Register notice: FDA posts a draft guidance entitled Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device ...
Two professors of medicine and law suggest ways FDA can encourage companies to complete confirmatory trials of drugs reaching market through the accel...
FDA warns Chinas Hubei Kangzheng Pharmaceutical Company about CGMP violations and manufacturing unapproved new drugs.
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.