In the Provisions for Communication About Drug R&D and Technical Review, "communication" means that in the process of drug R&D and the technical review of drug registration application, the applicant communicates with CDE reviewers about the pivotal technology and other issues that cannot be covered by drug R&D and evaluation guidance.
The meeting should be proposed by the application, deliberated by the CDE executive and the reviewer chosen by the applicant, and held after the approval of the CDE reviewer team.