FDA publishes a Covid-19 guidance on remote interactive evaluations of drug manufacturing and storage, bioresearch monitoring, and outsourcing facilit...
FDA acting FDA commissioner Janet Woodcock says the agencys pandemic recovery phase planning will prioritize facility surveillance and inspections.
FDA clears an expanded indication for the Avitus Bone Harvester.
FDA and CorMedix agree to a study protocol required in the agencys DefenCath complete response letter.
FDA and CDC recommend a pause in using the Johnson & Johnson (Janssen) Covid-19 vaccine due to concerns about potential blood clots.
Federal Register notice: FDA announces a 5/11-12 Oncologic Drugs Advisory Committees Pediatric Oncology Subcommittee meeting to review a patient-repor...
Federal Register notice: FDA, the National Institute of Allergy and Infectious Diseases, and the Centers for Disease Control and Prevention announce a...
Federal Register notice: FDA sends to OMB an information collection extension entitled Formal Dispute Resolution: Scientific and Technical Issues Rela...