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Guide on Pharmacogenomic Data Submissions

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Pharmacogenomic Data Submissions.

CDRH Modifies Electronic 510(k) Portal

[ Price : $8.95]

CDRH adds more functionality to its medical device electronic submission portal to prepare for an all-electronic submission proces...

Acufocus IOL Regulatory Review Period

[ Price : $8.95]

Federal Register notice: FDA determines for patent term extension purposes the regulatory review period for AcuFocus IC8 apthera i...

Regulatory Review Period for Jivi

[ Price : $8.95]

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Bayers hemophilia A therapy...

FDA Input on Rare Disease Development Needed: PhRMA

[ Price : $8.95]

Pharmaceutical Research and Manufacturers of America urges FDA to provide more input on the types of evidence that may be consider...

Keep Device Real-World Evidence Under NESTcc: MDMA

[ Price : $8.95]

Medical Device Manufacturers Association says it would be wasteful and duplicative to use medical device user fee funds to advance...

Athenex Cell Therapy on Clinical Hold

[ 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...

Remote Assessments May Be Model for Device Inspections

[ Price : $8.95]

Former CDRH Office of Compliance director Steven Silverman recommends device manufacturers look at FDAs remote regulatory assessme...

Accelerated Approval Mulled for Biogens Tofersen

[ Price : $8.95]

FDA reviewers appear open to considering accelerated approval for Biogens amyotrophic lateral sclerosis drug tofersen in patients ...

Guide on Clinical Trial Electronic Records

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Electronic Systems, Electronic Records, and Electronic Sign...