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Comments Sought on Drug Scheduling Recommendations

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Federal Register notice: FDA seeks comments concerning recommendations by the World Health Organization to impose international ma...

Philips BrightView CT System Recalled

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Philips North America recalls its BrightView computed tomography gamma camera system because of the risk of the detector unexpecte...

FDA Accepts Opdivo sNDA for New Indication

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FDA sets a 10/8 PDUFA action date for a Bristol Myers Squibb sNDA for Opdivo to treat some non-small cell lung cancers.

Amneal Refiles NDA for Parkinsons Drug

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Amneal Pharmaceuticals resubmits an NDA for IPX203, a novel oral formulation of carbidopa/levodopa extended-release capsules for t...

Prepare Now for QMSR Transition: Attorneys

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Four Hogan Lovells attorneys say medical device companies should begin now to prepare for the implementation of FDAs new Quality M...

Complex Generic/Hybrid Drugs Pilot Expands

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Office of Generic Drugs associate director of stakeholder and global engagement Sarah Ibrahim says FDA and EMA are evaluating a ne...

Gilead Nixes Leukemia Phase 3 Trial

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Gilead Sciences discontinues its Phase 3 ENHANCE-3 study of magrolimab in acute myeloid leukemia (AML) after FDA placed a clinical...

6 Info Collections Approved by OMB

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Federal Register notice: FDA posts a listing of six information collections that have been approved by OMB.

GSK Wins Priority Review for Expanded Use of RSV Vaccine

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FDA accepts for priority review a GSK supplemental BLA to extend the indication of its Arexvy adjuvanted respiratory syncytial vir...

Califf on How FDA Addresses Chronic Diseases

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FDA commissioner Robert Califf and two of his top associates describe how the agency uses its role to help address common chronic ...