[ Price : $8.95]
FDA signs a good pharmaceutical manufacturing practice mutual recognition agreement with Switzerland and its regulatory agencies.[ Price : $8.95]
CDRHs Suzanne Schwartz says FDA is glad it now has the legal authority to require medical device manufacturers to address cybersec...[ Price : $8.95]
Researchers call on the National Committee on Vital and Health Statistics to approve a proposal to add medical device unique ident...[ Price : $8.95]
FDA issues Biocon Biologics a complete response letter on its BLA for a biosimilar version of insulin aspart, citing additional da...[ Price : $8.95]
Physician advocacy group Doctors for America urges FDA to commit to convening an advisory committee meeting when it is time to con...[ Price : $8.95]
FDA warns two Olympus endoscope and reprocessor manufacturing facilities about Quality System and Medical Device Reporting regulat...[ Price : $8.95]
Pharmaceutical Research and Manufacturers of America raises some issues with the International Conference on Harmonization Q12 gui...[ Price : $8.95]
FDA posts a draft guidance entitled Photobiomodulation (PBM) Devices Premarket Notification 510(k) Submissions.