Navigating FDA meetings

Authors: Gerald L. Klein, MD+; Melissa Palmer, MD++; Freddy Byrth+; Roger E. Morgan, MD+; Thomas Krol, PharmD+; Seema Kumbhat, MD+++; Eric Hacherl, PhD++++, Shabnam Vaezzadeh, MD+++++

MedSurgPI+ Liver Consulting++ Ganglion Health+++ Smart Bio Works++++ Exquisite Biomedical Consulting+++++

Navigating FDA meetings is central to keeping drug, biologic, and device programs on track. This quick-reference chart highlights each meeting type’s purpose, timelines, and formality levels to help development teams plan more effectively and avoid delays