Redacting Personal Data/CCI In EU Clinical Trial Inspection Reports On The Agenda
Work is expected to start this year on developing guidance for the EU member states on how to redact clinical trial Inspection reports to protect personal data and commercially confidential information under the new Clinical Trials Regulation.
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The European Commission is inviting stakeholder feedback on recommendations to help implement several key aspects of the new EU Clinical Trials Regulation, including how to apply a risk proportionate approach for the design and conduct of trials, and how to present a summary of clinical trial results to laypersons1.
ICER president Steve Pearson is ‘cautiously optimistic’ that net pricing for acute migraine treatments will align with benefits once discounts are factored in.
Almost 50 novel agents are already under review at FDA for potential 2020 approval. Candidates are notably diverse, with concentrations in established strongholds (oncology, neuroscience), popular programs (breakthrough), and powerhouse sponsors (keep an eye on Bristol-Myers Squibb right out of the gate).