Opinions inside the US Food and Drug Administration on requiring fed studies in generic drug development may be softening.
New International Council for Harmonisation (ICH) guidance could eventually push the agency to mandate only fasting studies for most immediate-release solid oral dosage products
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?