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Industry Supports FDA Proposals on Biosimilars User Fees

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Presenters at an FDA-sponsored public meeting to consider a proposed user fee program for biosimilars offer uniform support for th...

FDA Monitoring Reports on Boston Scientific Promus Heart Stent

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FDA says it required a warning about longitudinal stent deformation on the labeling of Boston Scientifics Promus Element heart ste...

FDA OKs Baxters Advate for Hemophilia A

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FDA approves Baxter Internationals Advate for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patie...

FDA OKs Virbac Canine Otitis Treatment

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Federal Register Final rule: FDA approves a Virbac AH Inc. NADA for veterinary prescription use of a combination suspension for tr...

Comments Sought on List of Tobacco Constituents

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Federal Register Notice: FDA seeks comments on list of harmful tobacco constituents.

Info on Health/Nutrient Claim Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on a health claim or nutrient content claim to the Offic...

Report on Benefits/Risks of Rx Drugs

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Federal Register Notice: FDA releases a draft report on a quantitative summary of the benefits and risks of prescription drugs.

St. Jude Medical Class 1 Recall for Riata Defib Leads

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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

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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

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