AMIA Comments Regarding FDA PDUFA VI Commitment Letter

In conjunction with a public meeting held by the FDA August 15, 2016, AMIA submitted public comments supporting the direction of the its Prescription Drug User Fee Agreement Commitment Letter.  Specifically, AMIA supports FDA’s work to utilize Real World Evidence in regulatory decision-making, incorporating the patient’s voice in drug development and decision-making, advancing model-informed drug development and enhancing FDA’s Drug Surveillance System.