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Vanda Sues FDA Over Rejected Hetlioz sNDA

[ Price : $8.95]

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.

Medtronic Recalls Electromyogram Endotracheal Tubes

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Medtronic recalls its Xomed NIM Contact Reinforced Electromyogram (EMG) Endotracheal Tube and the NIM Standard Reinforced EMG Endo...

Inspection Form 483 for Alvotech Released by FDA

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FDA releases the FDA-483 citing 13 observations that were at the center of an Alvotech-received complete response letter on its bi...

Texas Longhorn RX Producing Illegal Drugs: FDA

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FDA warns Texas Longhorn RXs Talon Pharmacy of Boerne, Boerne Texas, about selling adulterated compounded drug products.

$2 Million FDA Grant to Marker Therapeutics

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FDA grants $2 million to Marker Therapeutics to support the treatment arm in a Phase 2 trial of its T-cell candidate to treat pati...

Preserve Access to Compounded Hormones: APC

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The Alliance for Pharmacy Compounding calls on FDA to reject recommendations in a National Academies report and instead maintain p...

Draft Guide on Device Maker Computer Software Assurance

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Federal Register notice: FDA makes available a draft guidance entitled Computer Software Assurance for Production and Quality Syst...

Right to Try Annual Summary Reporting Rule

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FDA publishes a final rule setting a new deadline for the annual summary report required under the Right to Try Law.