Table 3.

US/EU pathways depending on the regulatory goal of the interaction

Agencies	Early dialog	Acceptance for one trial	Qualification for specific COU (independent of a molecule)
US FDA	CPIM	IND path (e.g., type C meeting)	DDT program
EU EMA	ITF	Scientific advice	Qualification of novel methodologies

COU, context of use; CPIM, Critical Path Innovation Meeting; DDT, drug development tool; EU EMA, European Union European Medicines Agency; IND, Investigational New Drug; ITF, Innovation Task Force; US FDA, United States Food and Drug Administration.