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Info on Device Premarket Approval Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on premarket approval of medical devices to the Office o...

FTC Sues HGC Marketer for Deceptive Advertising

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The Federal Trade Commission sues the owner of two companies marketing HCG diet products for deceptive advertising.

Label Change on Potiga Over Eye Risks

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FDA approves label changes to GlaxoSmithKlines anti-seizure drug Potiga (ezogabine) to underscore risks of abnormalities to the re...

WLF Backs Device Group on 510(k) Complaints

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Washington Legal Foundation says it supports an earlier citizen petition criticizing the way FDA is changing the 510(k) program.

FDA Clears Tria Beauty Age-Defying Laser

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FDA clears a Tria Beauty 510(k) for its over-the-counter Age-Defying Laser and its use to reduce wrinkles.

FDA Orphan Drug Status for Joint Infection Therapy

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FDA has granted Cempra an orphan drug designation for Taksta (CEM-102) for treating prosthetic joint infections.

FDA Wants Lab Data in Systme International Unit Standards

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CDER and CBER consider requiring laboratory data in clinical trials that are measured and reported in Systme International units i...

FDA Working on Mammography Regulation Amendments

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FDA denies a petition seeking enforcement of mammography regulations and says it is developing proposed amendments to the regulati...

FDA Approves Impax/Tolmar Generic Solaraze

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FDA approves an Impax Laboratories and Tolmar ANDA for a generic version of PharmaDerms Solaraze Gel (diclofenac sodium-3%), indic...

Brovana Brochures Have Multiple Violations, OPDP Says

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CDERs Office of Prescription Drug Promotion says patient brochures for Sunovions Brovana make unsubstantiated efficacy claims and ...