The European Medicines is proposing to update its two existing guidelines on the clinical evaluation of medicines for treating bacterial infections and merge them into a single core document. The new document would clarify, among other things, considerations for the acceptance of single pivotal studies to support infection-site specific indications and pathogen-specific indications.
A draft version of the new guideline is expected to be issued for stakeholder consultation by the fourth quarter of...
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Pink Sheet for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?