Type B Meeting

Type B meetings include pre-IND meetings and pre-NDA/BLA meetings, while Type B(EOP) meetings are reserved for certain End-of-Phase 1 meetings (i.e., for 21 CFR Part 312 Subpart E or 21 CFR Part 314 Subpart H or similar products) and End-of-Phase 2/pre-Phase 3 meetings. Meetings regarding REMS or postmarketing requirements that occur outside the context of the review of a marketing application will also generally be considered Type B meetings.