Comment from Souad Messahel
AnonymousOtherIndividual
Summary: The commenter is seeking clarification on the regulatory expectations and procedures for submitting Pre-IND and IND applications using a master protocol framework for multiple investigational drugs. They are asking for confirmation on whether this framework is permissible for evaluating multiple agents within a single disease program.
Dear FDA,
We would appreciate clarification regarding the current regulatory expectations for submitting Pre-IND and IND applications under a master protocol that involves the clinical development of multiple investigational drugs intended to treat a single disease or condition.
Specifically, could you please confirm whether sponsors may now submit Pre-IND and IND applications utilizing a master protocol framework for the evaluation of multiple therapeutic agents within a single disease program, and provide any relevant guidance or considerations associated with such submissions?