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The HHS Inspection General says FDA is making progress in submitting clearance documents for FY 2015 and 2016 audit recommendation...[ Price : $8.95]
Former FDA commissioner Jane Henney and Chicago Community Fund CEO Helene Gayle urge FDA to reevaluate the distribution restrictio...[ Price : $8.95]
Regeneron asks FDA to clarify a draft guidance on developing endpoints for testing drugs intended to treat heart failure.[ Price : $8.95]
The Avoca Group explains the elements involved in taking a risk-based approach to clinical trial inspection readiness.[ Price : $8.95]
FDA issues an updated Clinical Outcome Assessment Compendium for use in determining how clinical outcome assessments may be used i...[ Price : $8.95]
SEC charges TherapeuticsMD with selectively sharing information with stock analysts after meeting with FDA on a product developmen...[ Price : $8.95]
Federal Register notice: FDA announces a 9/26 joint advisory committee meeting to discuss the pediatric-focused safety review for ...[ Price : $8.95]
Federal Register notice: FDA sends to OMB an information collection extension for drug Medication Guide Requirements.