Type B meetings under PDUFA Act (1 of 2) There are two types of Type B meetings under PDUFA Act. 1. Meetings before an Initial IND to conduct clinical trials is submitted (Pre-IND meeting). 2. Meetings before submission of Emergency-Use Authorization IND applications (Pre-emergency use authorization meeting). 3. Meetings before a marketing application is submitted (Pre-NDA or Pre-BLA meeting). 4. Meeting to discuss REMS or post marketing requirements (that fall outside of marketing application review). 5. Meetings to discuss development program of investigational drugs that are granted Breakthrough Therapy or Regenerative Medicine Advanced Therapy (RMAT) designation. #FDA #regulatoryaffairs #fdameetings #drugdevelopment
