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FDA Wants More Data on BMS Hepatitis C Drug

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FDA issues Bristol-Myers Squibb a complete response letter on its NDA for daclatasvir, an NS5A complex inhibitor for use in combin...

FDA Accepts Revive Therapeutics Gout Treatment IND

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FDA accepts Revive Therapeutics IND for bucillamine as a potential new gout treatment.

Dr. Reddys to Respond to FDA Inspection

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Indias Dr. Reddys says it will immediately implement remediations called for in a recent FDA inspection at its active pharmaceutic...

Grifols Gains FDA Approval for Plasma Production Facility

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FDA approves Grifols new plasma facility in Clayton, NC and will begin production next year.

FDA Faults Hospital for Morcellator Use without IDE

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CDRH deputy director for science William Maisel criticizes a Brigham and Womens Hospital clinical study for using now-restricted l...

MDR Violation at Nemschoff Chairs

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FDAs Minneapolis District Office warns Nemschoff Chairs about Medical Device Reporting violations involving its Serenity patient c...

FDA Extends Review of Novartis Myeloma Drug

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FDA extends by three months its review of a Novartis NDA for LBH589 (panobinostat) for use in combination with bortezomib and dexa...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Avena Botancials, Bodyhealth.com, Ebola-C Inc., Excelsior Medical, Navilyst Medi...

Guidance on Laparoscopic Power Morcellators

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Federal Register Notice: FDA releases a guidance: Product Labeling for Laparoscopic Power Morcellators.

FDA Clears Royal Phillips Iqon Spectral CT

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FDA clears a Royal Philips 510(k) for its IQon Spectral CT for use in computed tomography imaging.