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2nd Edition of New Tobacco Product Guidance

[ Price : $8.95]

Federal Register Notice: FDA releases a second edition of the guidance entitled Demonstrating the Substantial Equivalence of a New...

Some Concerns Over Radiofrequency Guidance

[ Price : $8.95]

Stakeholders ask for clarifications and editorial changes in an FDA draft guidance on assessing radiofrequency-induced heating.

Troy Innovative Instruments Needs Outside Expert: FDA

[ Price : $8.95]

FDA says Troy Innovative Instruments needs to retain an outside expert to audit and certify the firms compliance with the Quality ...

Attorney Hits Court Ruling on Warning Letters

[ Price : $8.95]

Reed Smith attorney James Beck criticizes as jurisfiction a Connecticut federal court ruling granting deference to FDA Warning Let...

FDA Policy Advisor Dwyer Moves to King & Spalding

[ Price : $8.95]

Former FDA Office of Policy senior advisor Lisa Dwyer joins King & Spalding as a partner.

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Apis Vida Industria, Cellestis, GiaLive, and Troy Innovative Instruments.

Comments Sought on Environmental Impact Info

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Federal Register Notice: FDA seeks comments on an agency collection of information: Environmental Impact Considerations.

Workshop on Next-generation Sequencing IVDs

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FDA announces a public workshop on Use of Databases for Establishing the Clinical Relevance of Human Genetic Variants."

Agency Accepts Valeant NDA for Relistor Tablets

[ Price : $8.95]

FDA accepts for review a Valeant Pharmaceuticals NDA for Relistor (methylnaltrexone bromide) tablets for treating opioid-induced c...

Nextremity Solutions Staple System Cleared by FDA

[ Price : $8.95]

FDA clears a Nextremity Solutions 510(k) for its Arcus Staple System, intended for use throughout the foot and ankle.