FDA accepts for review a Theravance Biopharma and Mylan NDA for revefenacin (TD-4208), an investigational long-acting muscarinic antagonist for treati...
Federal Register notice: FDA provides interested parties with the opportunity to submit written comments on recommendations by the World Health Organi...
FDA updates a guidance for Institutional Review Boards and Clinical Investigators to revise its Payment for Research Subjects: Information Sheet to cl...
FDA clears an electroCore 510(k) for an expanded label for gammaCore as an acute treatment of pain associated with migraine in adult patients.
FDA rejects an Aradigm NDA for Linhaliq (liposomal ciprofloxacin for inhalation) as a treatment for non-cystic fibrosis bronchiectasis patients with c...
FDA Review posts FDA-related Federal Register notices for the week ending 1/26/2018.
CDRH posts review metrics for its Accredited Persons Program for 510(k)s that shows the average decision time is more than twice as fast as traditiona...