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Sanofi Sues FDA Over Nasacort OTC Labeling Release

[ Price : $8.95]

Sanofi sues FDA seeking to block the release of the approved drug label for its over-the-counter Nasacort Allergy 24-hour nasal sp...

FDA Approves Aptiom for Partial Seizures

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FDA approves a Sunovion NDA for Aptiom (eslicarbazepine acetate) as an add-on medication to treat seizures associated with epileps...

FTC Finalizes Drug Patent Transfer Rules

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The Federal Trade Commission issues final changes to rules requiring drug companies to report some proposed acquisitions of patent...

Guidance on Clinical Device Studies

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Federal Register Notice: FDA releases a guidance on Design Considerations for Pivotal Clinical Investigations for Medical Devices.

Panel to Discuss Spinal Devices, Wheelchairs

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Federal Register Notice: FDAs Orthopedic and Rehabilitation Devices Panel will meet 12/12 to discuss the classification of spinal ...

FDA Approves Hologic Aptima HPV Assay

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FDA approves a Hologic PMA for the Aptima HPV 16 18/45 genotype assay for use on the companys fully automated Panther system.

Info on Expedited Programs Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on a guidance on expedited drug and biologic programs fo...

Draft Hearing Aid/PSAP Guidance Out

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CDRH issues a draft guidance on regulatory requirements applying to hearing aids and personal sound amplification products dependi...

FDA Orphan Status for Patrys Anti-cancer Drug

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FDA grants Patrys Limited an orphan drug designation for its lead anti-cancer product PAT-SM6 for treating multiple myeloma.

FDA Clears TiO2Mesh for Hernia Repair

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FDA clears a BioCer Entwicklungs 510(k) for its TiO2Mesh hernia repair system for repairing soft tissue defects in the abdominal w...