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Panel to Discuss Duchenne Muscular Dystrophy Drug

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Federal Register Notice: FDAs Peripheral and Central Nervous System Drugs Advisory Committee will meet 1/22/16 to discuss a Sarept...

Biosimilars Council Weighs In on User Fee Reauthorization

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The Biosimilars Council says FDA should codify the currently outstanding biosimilars regulations to expedite access to these alter...

FDA Clears Life Spines Cervical Plate

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FDA clears a Life Spine 510(k) for the GRUVE Anterior Cervical Plate System for use in spinal surgeries.

FDA Approves New Pediatric Indication for LifeVest

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FDA approves a new pediatric indication for Zoll Manufacturings LifeVest, a wearable cardioverter defibrillator.

FDA Clears Oculus Seborrhea Gel

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FDA clears an Oculus Innovative Sciences 510(k) for its Microcyn-based SebDerm Gel, intended for use in managing and relieving the...

Info on Safety Labeling Changes Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on a guidance on safety labeling changes to the Office o...

Vancomycin HCl Products Not Withdrawn for S&E

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Federal Register Notice: FDA determines that Vancocin, Vancoled, and Vancocin Hydrochloride were not withdrawn from sale for reaso...

Guidance on IND Safety Reporting Assessment

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Federal Register Notice: FDA releases a draft guidance: Safety Assessment for IND Safety Reporting.

FDA OKs ANI Pharmas Generic Miralax

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FDA approves an ANI Pharmaceuticals ANDA for polyethylene glycol 3350 powder for oral solution, 17mg per scoopful, a generic copy ...

Catalyst Files NDA for Firdapse

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Catalyst Pharmaceuticals completes a rolling NDA submission for Firdapse (amifampridine phosphate), indicated for treating Lambert...