(8-139) Uncovering Regulatory Affairs CMC Trends in FDA Complete Response Letters (CRLs): A Data Mining Analysis of Over 200 CRLs to Inform Regulatory Strategy

Tuesday, December 9, 2025

2:00 PM - 3:30 PM

Location: Bayside A, Level 1

Fellowship Program: Boehringer Ingelheim PharmD Postdoctoral Fellowship - Regulatory Affairs Chemistry, Manufacturing, & Controls (CMC)
Fellowship Location: Connecticut

Co-Author(s): Lucas Ciriello, Chinonso Paul, Nina Rocchio, Janette Wadolowski

Primary Author(s)

Shikha S. Patel, PharmD, RPh

Regulatory Affairs Chemistry, Manfacturing, & Controls (CMC) Postdoctoral Fellow
Boehringer Ingelheim