Product Application Meetings (continued) Type B meetings generally occur in the following order: Pre-Investigational New Drug (IND) meetings (21 CFR 3
{"Image DocumentName": "Product Application Meetings (continued)", "Image ImageDescription": "Type B meetings generally occur in the following order: Pre-Investigational New Drug (IND) meetings (21 CFR ) Certain End-of-Phase 1 meetings (21 CFR ) End of Phase 2 meetings/Pre-Phase 3 meetings (21 CFR ) Pre-NDA/Biologic License Application (BLA) meetings (21 CFR ) Sponsors should only request one of each of these Type B meetings (pre-NDA meeting is intended to discuss formatting of the submission) 3. Type C Meeting: discussion of any other product development meeting not included in Type A or B. meeting will be scheduled within 75 days of receipt of a written request. process for requesting a meeting is the same as for Types A and B. meeting packages should be submitted to FDA at least four weeks before the formal meeting.", "Image XResolution": "37", "Image YResolution": "37", "Image ResolutionUnit": "Pixels/Centimeter", "Image Software": "SlidePlayer", "Image YCbCrPositioning": "Centered"}