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Regulatory Review Period for Bulkamid

[ Price : $8.95]

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Conturas Bulkamid Urethral ...

Affirm Dismissal of Lexapro Case: WLF

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The Washington Legal Foundation says the 2nd Circuit Court of Appeals should affirm a lower courts dismissal of a suit against For...

Rule on Right to Try Act Annual Summaries

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Federal Register notice: FDA issues a final rule specifying the deadline and content for submission of annual summaries under the...

Vanda Sues FDA Over Rejected Hetlioz sNDA

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Vanda Pharmaceuticals files a lawsuit against FDA seeking an order to compel it to publish in the Federal Register a notice of opp...

3 Observations on Aurobindo FDA-483

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FDA releases a form FDA-483 with three observations from an inspection at an Aurobindo active pharmaceutical ingredient manufactur...

FDA Clears Conformis Tapered Hip System

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FDA clears a Conformis 510(k) for its Acter Hip System to add a tri-taper femoral stem design to the device portfolio.

FDA Rejects Hearing Aid Standardization

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FDA denies a petition asking it to standardize hearing aid features in new over-the-counter hearing aids and rate them.

FDA Partnership on Rare Neurodegenerative Diseases

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FDA joins the National Institutes of Health in launching a Critical Path for Rare Neurodegenerative Diseases public-private partne...

FDA Determines Review Period for Migraine Drug

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Eli Lillys migraine drug Re...

Bob Temple Gets New Title, Role Remains the Same

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CDER director Patrizia Cavazzoni removes Bob Temples deputy Center director title and renames him senior advisor for clinical scie...