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FDA Launches CURE ID Internet Repository

[ Price : $8.95]

FDA launches its CURE ID Internet-based repository for reporting experiences using approved drugs in new ways to treat hard-to-tre...

Genus Lifesciences Protests FDA Actions on Lannett Application

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Genus calls on FDA to rescind its acceptance of a Lannett 505(b)(2) application for a cocaine hydrochloride product.

Groups Question FDA Weight Loss Paper

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Several professional groups take issue with provisions in an FDA discussion paper on a benefit/risk approach for medical devices f...

Guide on Interstitial Cystitis/Bladder Pain Syndrome

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Federal Register notice: FDA makes available a draft guidance entitled Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS): Estab...

EmCyte Progenikine Concentrating System Cleared

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FDA clears an EmCyte 510(k) for its Progenikine Concentrating System for adipose lipoplasty.

Interstitial Cystitis Drug Effectiveness Guidance

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FDA publishes a draft guidance with recommendations for establishing effectiveness for drugs intended to treat patients with inter...

Pilot Considered on Evaluating Novel Excipients

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Federal Register notice: FDA establishes a docket to obtain information and comments that will assist it in determining whether to...

CDRH Industry Basics Webcast

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A CDRH Industry Basics webcast gives basic program information on the 513(g) device determination and classification process and t...

Reg Review Period for Sparks Luxturna

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Spark Therapeutics Luxturna...

Jobs Lost if Medical Device Tax Not Repealed: Analysis

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AdvaMed says that if Congress does not repeal the medical device tax before the end of the year, more than 20,000 industry jobs wi...