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CBER director Peter Marks tells a Muscular Dystrophy Association conference about ways FDA is addressing barriers to developing ge...[ Price : $8.95]
CDER submits a petition outlining its requests if the FDA chief scientist decides to grant Intarcia a hearing on its NDA for drug/...[ 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Federal Register notice: FDA makes available a draft guidance entitled Pharmacogenomic Data Submissions.[ Price : $8.95]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...