FDA launches pilot program in support of complex trial designs for drugs and biologics
The FDA announced a new pilot program Wednesday aimed at encouraging the use of complex innovative trial designs in the development of drugs and biologics.
Sponsors selected by the FDA based on the criteria for participation in the “Complex Innovative Designs Pilot Meeting Program” will be able to engage staff in early discussions on approaches to complex designs.
The pilot will remain operational through 30 September 2022, but sponsors have until 30 June 2022 to submit meeting requests, according to Wednesday’s notice. Meetings under the pilot will be conducted by FDA’s Center for Drug Evaluation and Research or its Center for Biologics Evaluation and Research.
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