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St. Jude Medical Class 1 Recall for Riata Defib Leads

[ Price : $8.95]

FDA classifies an 11/28 St. Jude Medical medical device advisory letter to physicians about the performance of Riata and Riata ST ...

FDA Clears Mobile App for Medical Images

[ Price : $8.95]

FDA clears an MIM Software 510(k) for the Mobile MIM 3.0 for diagnostic X-ray and ultrasound viewing.

FDA OKs AtriCure Ablation System for AF

[ Price : $8.95]

FDA approves the AtriCure Synergy Ablation System for treating patients with persistent and long-standing persistent atrial fibril...

Panel to Discuss sNDA for HIV-associated Neuropathy

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Federal Register Notice: FDAs Anesthetic and Analgesic Drug Products Advisory Committee will meet 2/9.

Panel to Discuss Pediatric Safety Reviews

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Federal Register Notice: FDAs Pediatric Advisory Committee will meet 1/30-31/12 to discuss several pediatric-focused safety review...

FDA OKs Intervet NADA for Canine Incontinence

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Federal Register Final rule: FDA approves an Intervet NADA for use of estriol tablets to control canine urinary incontinence.

Guidance on Humanitarian Use Devices

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Federal Register Notice: FDA releases a draft guidance, on Humanitarian Use Device designations.

ProstaScint Fact Sheet Misleading: OPDP

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CDERs Office of Prescription Drug Promotion says an EUSA ProstaScint fact sheet fails to provide important information, overstates...

FDA Not Requiring REMS for Cushings Drug

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FDA tells Corcept Therapeutics that it will not require a Risk Evaluation and Mitigation Strategy program as part of its NDA submi...

Rep Cited for False, Misleading Latuda Statements

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CDERs Office of Prescription Drug Promotion says that a Sunovion sales representative made false or misleading statements about La...