Significant changes from the 2009 version include:
Addition of the written response meeting format for pre-investigational new drug application (pre-IND) and Type C meetings
Designation of a post-action meeting requested within 3 months after an FDA regulatory action other than approval as a Type A meeting
Designation of a post-action meeting requested 3 or more months after an FDA regulatory action other than approval as a Type B meeting
Designation of a meeting regarding risk evaluation and mitigation strategies (REMS) or post-marketing requirements that occur outside the context of the review of a marketing application as a Type B meeting
Inclusion of a meeting package in Type A meeting requests
Designation of meetings to discuss the overall development program for products granted 59 breakthrough therapy designation status as a Type B meeting
Comments and suggestions regarding this draft document should be submitted by June 9, 2015. Submit electronic comments to www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with Docket No. FDA-1999-D-1315 (formerly 1999-D-0296).