The Avoca Group explains the elements involved in taking a risk-based approach to clinical trial inspection readiness.
FDA issues an updated Clinical Outcome Assessment Compendium for use in determining how clinical outcome assessments may be used in clinical trials.
SEC charges TherapeuticsMD with selectively sharing information with stock analysts after meeting with FDA on a product development issue.
Federal Register notice: FDA announces a 9/26 joint advisory committee meeting to discuss the pediatric-focused safety review for oxycodone hydrochlor...
Federal Register notice: FDA sends to OMB an information collection extension for drug Medication Guide Requirements.
National Center for Health Research president Diana Zuckerman says FDA was wrong to not make public an adverse event summary reporting system it allow...
CBER director Peter Marks says his public criticism of Novartis Zolgensma data manipulation was intended to maintain public trust in gene therapies.
FDA grants Astellas Pharma and Pfizer a priority review for their supplemental NDA for Xtandi (enzalutamide) for treating men with metastatic hormone-...