MIDD Paired Meeting Program

Accelerate your development program by leveraging the FDA’s MIDD Paired Meeting Program

Accelerate your development program by leveraging the FDA’s MIDD Paired Meeting Program. Our integrated clinical pharmacology and pharmacometrics team, including world-renowned MIDD leader Jack Cook, will work with your team to outline the MIDD strategy, author and review submission documents, and execute the modeling approach aligned with the FDA. Successful outcomes include advancing from Phase 1b to Phase 3 based on virtual dose-ranging Phase 2 trials and approval of a new dosage form based on virtual Phase 3 clinical trial simulations.