Complex Innovative Designs Pilot Likely Satisfies Industry's Disclosure Worries
US FDA says sponsors generally won’t need to publicly disclose company or product if selected for pilot, but rather elements about design of their complex trial.
You may also be interested in...
If they reach a public disclosure agreement, a handful of sponsors will be admitted to a new pilot program that allows four meetings with the FDA on rare disease endpoint issues.
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.
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.