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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 ...

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...

Ionis Reports Positive Olezarsen Trial Data

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Ionis Pharmaceuticals reports positive topline results from the Essence study of olezarsen in people with moderate hypertriglyceri...

Novavax Covid Vaccine Approved After Trial Agreement

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FDA approves a Novavax BLA for traditional approval of Nuvaxovid for active immunization to prevent Covid-19 that includes a more ...

Severe Itching Linked to Allergy Drugs

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An FDA safety alert warns that patients who stop taking oral allergy medicines cetirizine or levocetirizine after long-term use ma...

Stryker Nerve Ablator Cleared for Back Pain

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FDA clears a Stryker 510(k) for its OptaBlate basivertebral nerve ablation system and its use for procedures providing vertebrogen...