Researchers call on the National Committee on Vital and Health Statistics to approve a proposal to add medical device unique identifiers to health sys...
FDA issues Biocon Biologics a complete response letter on its BLA for a biosimilar version of insulin aspart, citing additional data being needed and ...
Physician advocacy group Doctors for America urges FDA to commit to convening an advisory committee meeting when it is time to consider the full appro...
FDA warns two Olympus endoscope and reprocessor manufacturing facilities about Quality System and Medical Device Reporting regulation violations.
Pharmaceutical Research and Manufacturers of America raises some issues with the International Conference on Harmonization Q12 guidance published by F...
FDA posts a draft guidance entitled Photobiomodulation (PBM) Devices Premarket Notification 510(k) Submissions.
FDA approves an AstraZeneca NDA for Airsupra (albuterol/budesonide) for the as-needed treatment or prevention of bronchoconstriction and to reduce the...
Federal Register notice: FDA issues an emergency use authorization for a Life Technologies in vitro diagnostic device for detecting and diagnosing mon...
