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FDA Accepts Otsuka NDA Resubmission for Tolvaptan

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FDA accepts an Otsuka Pharmaceutical Co. NDA resubmission for tolvaptan and its expanded use in treating adults with Autosomal Dom...

FDA Awards Grants to Advance Pediatric Drug Studies

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FDA awards Advanced Clinical Trials for Children and Duke University each $1 million to help advance pediatric clinical trials.

FDA Denies Fresenius Keryx Petition

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FDA denies a Fresenius petition asking it not to approve a Keryx sNDA for Auryxia.

FDA Wants to Reduce Companies Gaming REMS

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FDA commissioner Scott Gottlieb describes steps the agency is taking to facilitate approval of shared system REMS in an effort to ...

CDER Seeking Input on Study Data Template

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Federal Register notice: CDER seeks comments on a proposed Analysis Data Reviewers Guide (ADRG) template that was developed under ...

Ad Group Refers Synergy Claims to FTC

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The Better Business Bureaus National Advertising Division says Synergy Pharmaceuticals declined to participate in a self-regulator...

Drug Companies Greater Use of Real-World Evidence: Report

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A Tufts Center for the Study of Drug Development company survey finds that use of real-world evidence is increasing and will grow ...

Device Recalls Down, Drug Recalls Up in 3rd Quarter

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Stericycles third quarter 2017 recall index says medical device recalls fell, while drug recalls increased.

Guide on Recurrent Herpes Labialis Drug Development

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Federal Register notice: FDA makes available a guidance on Recurrent Herpes Labialis (RHL): Developing Drugs for Treatment and Pre...

Proposed Info Collection on Target Product Profile Guide

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Federal Register notice: FDA submits to OMB a new proposed information collection supporting its Draft Guidance for Industry and R...