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Stakeholders Praise, Pan UDI Proposal

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Stakeholders tell FDA they see the value in a medical device unique identifier but find problems with the agencys proposed regulat...

FDA Wont Revoke Daliresp Approval

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FDA denies a Physicians for Integrity in Medical Research petition to revoke approval of Daliresp.

Auxilium Files sBLA for Xiaflex in Peyronies Disease

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Auxilium Pharmaceuticals files a supplemental BLA for Xiaflex (collagenase clostridium histolyticum) for treating Peyronie's disea...

Panel to Discuss Reclassification of Devices

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Federal Register Notice: FDAs Circulatory System Devices Panel will meet 12/5-6 to discuss reclassification for three pre-amendmen...

Merck FDA-483 Cites Puerto Rico Facility

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An FDA inspection of Mercks Arecibo, Puerto Rico manufacturing facility cites the firm for having a deficient control to prevent c...

Boehringer Ingelheim Reports Interim Results of Pradaxa Trial

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Boehringer Ingelheim says interim results of a long-term extension of a Phase 3 trial of Pradaxa showed similar key safety outcome...

FDA Panel Back Novartis Cushings Drug

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FDAs Endocrinologic and Metabolic Drugs Advisory Committee votes to recommend approval for Novartis Pharmaceuticals NDA for Signif...

Intersect ENT Sinusitis Implant Approved

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FDA approves Intersect ENTs steroid-releasing product, Propel mini (mometasone furoate), for treating chronic sinusitis.

Halt Medical Uterine Fibroid Blaster Cleared

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FDA clears a Halt Medical 510(k) for the Acessa for treating women suffering from uterine fibroids.

CGMP Violations Found at International Laboratories

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FDA warns International Laboratories (Canada) about CGMP and labeling violations in its manufacturing of OTC drugs.