Snapshot

The Model-Informed Drug Development Paired Meeting Program pathway has been developed by the of United States.

This pathway can be used where (i) Drug/Biologics development company with an active IND or PIND number for the relevant development program (ii) Interested consortia or software/device developer should come in partnership with a drug development company (iii) This excludes statistical designs involving complex adaptations, Bayesian methods, or other features requiring computer simulations to determine the operating characteristics of a confirmatory clinical trial.

This pathway facilitates activities during development.

It is an abridged review (a reliance pathway).

Under the paired meeting program, FDA will accept 1-2 paired-meeting requests quarterly each year throughout the PDUFA VII period. Additional proposals that meet the eligibility criteria may be selected depending upon the availability of resources. For each meeting request granted as part of the paired meeting program, FDA will conduct an initial and follow-up meeting on the same drug development issues. Timeline for meeting background package submission: All meeting packages are due no later than 47 days before the initial (first) meeting and 60 days before the follow-up (second) meeting. Timing and scheduling of the follow-up meeting: After the initial meeting has been held, the follow-up (second) meeting will be scheduled to occur within approximately 60 days of receiving the meeting package. A meeting summary will be sent to the requester within 30 days of each meeting.