FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

GSK Narrows Zejula Indication at FDAs Request

[ Price : $8.95]

GSK says it has complied with an FDA request to restrict the second-line maintenance indication for cancer drug Zejula (niraparib)...

FTC Takes Issue with Jazz Orange Book Listing

[ Price : $8.95]

The FTC files an amicus brief with the Delaware federal court in the case of Jazz Pharmaceuticals v. Avadel CNS Pharmaceuticals, t...

Imfinzi/Imjudo OKd for Lung Cancer

[ Price : $8.95]

FDA approves AstraZenecas Imfinzi (durvalumab) in combination with Imjudo (tremelimumab) plus platinum-based chemotherapy for trea...

DiaSorin Cytomegalovirus Assay for Infants Cleared

[ Price : $8.95]

FDA clears a DiaSorin 510(k) for its Simplexa Congenital CMV Direct kit, a molecular diagnostic test that detects cytomegalovirus ...

Device Definition Guidance

[ Price : $8.95]

FDA publishes a guidance on using definitions for device and counterfeit device.

ICH Guide on Cell-line Product Viral Safety

[ Price : $8.95]

FDA seeks comments on a draft guidance entitled Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human...

Expedited Program Quality Assessment MAPP

[ Price : $8.95]

The CDER Office of Pharmaceutical Quality publishes a MAPP on its use of regulatory flexibilities to help overcome CMC readiness c...

FDA Determines Regulatory Period for Xcopri

[ Price : $8.95]

Federal Register notice: FDA determines for patent term extension purposes the regulatory review period for SK Biopharmaceuticals ...

Tissueblue Regulatory Review Determined

[ Price : $8.95]

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Dutch Ophthalmics Tissueblu...

Regulatory Review Period for Nexletol

[ Price : $8.95]

Federal Register notice: FDA determines the regulatory review period for Esperion Therapeutics Nexletol (bempedoic acid), indicate...