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FDA Didnt Submit OIG Clearance Documents: Report

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The HHS Inspection General says FDA is making progress in submitting clearance documents for FY 2015 and 2016 audit recommendation...

End Mifepristone Distribution Restrictions: Authors

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Former FDA commissioner Jane Henney and Chicago Community Fund CEO Helene Gayle urge FDA to reevaluate the distribution restrictio...

Regeneron Seeks Heart Failure Guidance Clarifications

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Regeneron asks FDA to clarify a draft guidance on developing endpoints for testing drugs intended to treat heart failure.

Risk-Based Inspection Approach Explained

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The Avoca Group explains the elements involved in taking a risk-based approach to clinical trial inspection readiness.

Updated COA Compendium Out

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FDA issues an updated Clinical Outcome Assessment Compendium for use in determining how clinical outcome assessments may be used i...

Drug Co. Charged with Unfairly Disclosing FDA Info

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SEC charges TherapeuticsMD with selectively sharing information with stock analysts after meeting with FDA on a product developmen...

Joint Panel to Review Pediatric-use Opioids

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Federal Register notice: FDA announces a 9/26 joint advisory committee meeting to discuss the pediatric-focused safety review for ...

Info Collection Extension for Med Guides

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Federal Register notice: FDA sends to OMB an information collection extension for drug Medication Guide Requirements.

Device Alternate Reports Inappropriate, Unfair: Zuckerman

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National Center for Health Research president Diana Zuckerman says FDA was wrong to not make public an adverse event summary repor...

FDA Explains Novartis Data Manipulation Stance

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CBER director Peter Marks says his public criticism of Novartis Zolgensma data manipulation was intended to maintain public trust...