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Comment Period Extended on IRB Proposed Rules

[ Price : $8.95]

Federal Register notice: FDA extends by two months the comment period on two proposed rules that appeared in the 9/28 Federal Regi...

GSK Narrows Zejula Indication at FDAs Request

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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

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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

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

DiaSorin Cytomegalovirus Assay for Infants Cleared

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

Device Definition Guidance

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

ICH Guide on Cell-line Product Viral Safety

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FDA seeks comments on a draft guidance entitled Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human...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

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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

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

Tissueblue Regulatory Review Determined

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