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Info on E-Reporting for Compounding Outsourcing Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information to the Office of Management and Budget on a guidance on ...

FDA Seeks Selectors, Nominations for Tobacco Panel

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Federal Register Notice: FDA seeks industry participants for selecting a tobacco grower representative for the Tobacco Products Ad...

Par Complaint Seeks to Ban Potassium Chloride Supplements

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Foley & Larder reports that a complaint on behalf of Par against potassium chloride powder product imports moves to an administrat...

DC Court Rules for FDA on Marketing Exclusivity

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The DC federal court rules in FDAs favor in a lawsuit brought by Otsuka that sought to reverse the agencys approval of Alkermes 50...

FDA Approves Transcend Glaucoma Device

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FDA approves a Transcend Medical PMA for the CyPass Micro-Stent System (Model 241-S), a glaucoma surgical device for use in combin...

Device Single Audit Program Posts Records Control Document

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CDRH posts a Medical Device Single Audit Program document that outlines the control of quality records generated under the pilot p...

Fast Track for Shire Liver Fibrosis Drug

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FDA grants Shire a fast track designation for SHP626 (volixibat), an investigational drug for treating adults who have nonalcoholi...

CDRH Addresses Medical Device Biocompatibility Testing

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A CDRH webinar reviews medical device biocompatibility issues addressed in a recent a guidance on Use of International Standard IS...

Sen. Schumer Calls for FDA Probe on Sunscreens

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Senator Charles Schumer (D-NY) calls on FDA to launch an investigation into deceptive sun protection factor marketing, following a...

NIH Researchers Develop Drug Discovery Tool

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A team of NIH researchers develop a new software tool called AptaTRACE for drug developers and other scientists who want to identi...