FDA releases new guidance document in April 2015 regarding Critical Path Innovation Meetings (CPIM). The document strives to provide insight to pharmaceutical companies and the public regarding the acceleration of the drug development process through the Critical Path Initiative. CPIM are designed to communicate with industry experts, patient advocacy groups, and government to improve efficiency and success in drug development. The meetings allow FDA to provide its perspective on the use of proposed new tools and methods in drug development as well as gain exposure to new techniques that have potential value in the drug development process. Furthermore, the guidance provides examples of appropriate topics for Critical Path Innovation Meetings and the information needed to request a meeting.
To access FDA guidance document, click here. For additional information, read Alexander Gaffney’s article from RAPS.org.