Industry and US Food and Drug Administration representatives may be considering multiple biosimilar supplement review timelines depending on application type as part of the user fee reauthorization, which could help quicken some reviews and address an issue sponsors complained was hindering uptake.
Both sides reviewed ideas to improve the supplement approval process during a 30 March biosimilar user fee reauthorization negotiation session. FDA and industry officials gave proposals on “supplement categorization” and review timelines
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?