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FDA Approves Bayers Jivi Antihemophilic Factor

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FDA expands its approval of Bayers Jivi for the routine prophylactic treatment of hemophilia A in previously treated adult and ped...

Panel Wants More U.S. Patient Data on Glofitamab

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FDAs Oncologic Drugs Advisory Committee says there are insufficient number of U.S.-treated patients in a clinical trial supporting...

PDUFA Public Meeting for User Fee Reauthorization

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Federal Register notice: FDA announces a 7/14 public meeting to discuss proposed recommendations for the reauthorization of the Pr...

Generic Drug Fee Program Reauthorization Meeting

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Federal Register notice: FDA hosts a 7/11 public meeting on the reauthorization of the Generic Drug User Fee Amendments (GDUFA) fo...

CGMP Violations in NWL Netherlands Inspection

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FDA warns Netherlands-based NWL Netherlands Services about CGMP violations in its production of finished drugs.

48 New, Revised PSGs Out

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FDA publishes 34 new and 14 revised product-specific guidances to aid in generic drug development.

Miller Named Acting Inspections Chief

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FDA names Elizabeth Miller acting associate commissioner of the Office of Inspections and Investigations (OII), replacing Michael ...

FDA Chief Counsel Post on Hold for Now

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HHS deputy general counsel Bob Fox Foster says FDAs chief counsel post will remain vacant until after president Trumps nominee, We...

Formycon Wins Stelara Interchangeability for Biosimilar

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FDA designates Formycons FYB202/Otulfi (ustekinumab-aauz) as an interchangeable biosimilar to Janssens reference biologic Stelara ...

FDA Policy Head on Major Trump Changes at FDA

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FDA deputy commissioner for policy, legislation, and international affairs Grace Graham highlights major changes coming to FDA und...