A full revision of the US Food and Drug Administration’s Q-submission (Q-Sub) guidance document, which details how manufacturers may request meetings with the agency, is coming. But while that is in the works, the agency has issued a new version of the 2019 final guidance that attempts to clarify a range of issues.
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Medtech Insight 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?