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HHS Outlines FDA Projects Under Biotech Initiative

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HHS details specific FDA projects that will be undertaken as part of President Bidens recent Executive Order launching a National ...

3 Notices on Animal Minor Use/Major Species

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Federal Register notices: FDA publishes three notices about its most recent periodic reassessment of the definition of small numbe...

Pfizer Plans BLA for New Meningococcal Vaccine

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Pfizer says it will file a BLA before year end for its pentavalent meningococcal vaccine (MenABCWY).

FDA Panel to Discuss Kidney Disease Drug

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Federal Register notice: FDA announces an 11/16 advisory committee meeting to discuss an Ardelyx NDA for tenapanor hydrochloride t...

Heron Gets NDA Approved for Aponvie

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FDA approves a Heron Therapeutics NDA for Aponvie (aprepitant) injectable emulsion, indicated for preventing postoperative nausea ...

ICH Guide on Elemental Impurities

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Federal Register notice: FDA releases a final guidance entitled Q3D(R2) Guideline for Elemental Impurities.

Bacitracin Withdrawn Due to Safety: FDA

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Federal Register notice: FDA determines that intramuscular antibiotic bacitracin for injection, 10,000 units/vial and 50,000 units...

Akorn Pays $7.9 Million to Resolve False Claims Suit

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Akorn pays $7.9 million to resolve allegations that it caused Medicare to submit false claims by delaying an Rx to OTC switch for ...

Top FDA-483, Warning Letter Observations

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A MasterControl white paper lists the processes involved in the most common FDA medical device observations and Warning Letters.

FDA Grants, Denies Catalyst Amifampridine Petition

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FDA grants in part and declines in part a Catalyst Pharmaceuticals petition on using amifampridine to treat congenital myasthenic ...