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Turn Gene Therapy into Reality: Marks

[ Price : $8.95]

CBER director Peter Marks tells a Muscular Dystrophy Association conference about ways FDA is addressing barriers to developing ge...

CDERs Requests for Intarcia Hearing

[ 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/...

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Federal Register notice: FDA makes available a draft guidance entitled Pharmacogenomic Data Submissions.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