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FDA Warns Sarfez About Soaanz Promotional Materials

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The CDER Office of Prescription Drug Promotion warns Sarfez Pharmaceuticals that promotional materials for its Soaanz edema drug c...

Covid Vaccine Policy on Boosters and New Trials

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FDA commissioner Marty Makary and CBER director Vinay Prasad outline a new regulatory framework for annual Covid-19 booster shots...

SSRI/SNRI Labeling Changes Sought

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The Antidepressant Coalition for Education petitions FDA to change labeling for selective serotonin reuptake inhibitors and seroto...

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.

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 ...