Federal Register notice: FDA makes available a draft guidance entitled Pharmacogenomic Data Submissions.
CDRH adds more functionality to its medical device electronic submission portal to prepare for an all-electronic submission process.
Federal Register notice: FDA determines for patent term extension purposes the regulatory review period for AcuFocus IC8 apthera intraocular lens.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Bayers hemophilia A therapy Jivi.
Pharmaceutical Research and Manufacturers of America urges FDA to provide more input on the types of evidence that may be considered in rare disease d...
Medical Device Manufacturers Association says it would be wasteful and duplicative to use medical device user fee funds to advance real-world data/evi...
FDA issues a clinical hold against Athenex and Baylor College of Medicines kUR-501 after the death of a young heavily pretreated male patient.
Former CDRH Office of Compliance director Steven Silverman recommends device manufacturers look at FDAs remote regulatory assessment program as a temp...
