US FDA, Industry Share Early Lessons From Complex Innovative Trial Designs Program
Executive Summary
Timelines in the CID program are tight, and sponsors should have a ‘fully baked’ trial design before heading into their first meeting with the agency, industry reps say; agency needs more simulation data from participating sponsors earlier and is working to ensure continuity for firms after the second of two meetings allowed under the program.
You may also be interested in...
Patient-Focused Drug Development, Complex Trial Design May Not Get More Funding In PDUFA VII
US FDA proposed increasing staffing and resources for both programs during the next user fee program cycle, but industry representatives did not believe it necessary.
PDUFA VII Talks To Begin With COVID-19, Other Familiar Issues To Consider
US FDA staffing problems and patient engagement enhancements will be listed as priorities during reauthorization kick-off meeting.
Neurology At The Forefront Of US FDA Complex Innovative Trial Design Pilot
Wave’s Duchenne muscular dystrophy drug crashed, but Lilly’s chronic pain R&D will test the agency’s CID meeting pilot program, while FDA issues draft guidance that highlights potential uses for complex innovative trial designs.