[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Pharmacogenomic Data Submissions.[ Price : $8.95]
CDRH adds more functionality to its medical device electronic submission portal to prepare for an all-electronic submission proces...[ Price : $8.95]
Federal Register notice: FDA determines for patent term extension purposes the regulatory review period for AcuFocus IC8 apthera i...[ Price : $8.95]
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Bayers hemophilia A therapy...[ Price : $8.95]
Pharmaceutical Research and Manufacturers of America urges FDA to provide more input on the types of evidence that may be consider...[ Price : $8.95]
Medical Device Manufacturers Association says it would be wasteful and duplicative to use medical device user fee funds to advance...[ Price : $8.95]
FDA issues a clinical hold against Athenex and Baylor College of Medicines kUR-501 after the death of a young heavily pretreated m...[ Price : $8.95]
Former CDRH Office of Compliance director Steven Silverman recommends device manufacturers look at FDAs remote regulatory assessme...