Type B Meetings

Examples of type B meetings include:

Pre-investigational new drug application (pre-IND) meetings
Certain end-of-phase 1 meetings for Subpart E or Subpart H or similar products
End-of-phase 2 and pre-phase 3 meetings
Pre-new drug application (pre-NDA) pre-biologics license application (pre-BLA) meetings
Meetings regarding risk evaluation and mitigation strategies (REMS) or post-marketing requirements that occur outside the context of the review of a marketing application
Post-action meetings requested by the sponsor 3 months or more after an FDA regulatory action other than an approval
Meetings held to discuss the overall development program for products granted Breakthrough Therapy designation status.

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