Module 12 2019

Legal Basis: FDA Safety and Innovation Act (FDASIA) of 2012

Section 1136: Allows FDA to require standardized fully electronic submissions related to marketing applications

• Twenty-four (24) months after publication of the final guidance: New Drug Applications (NDAs) and Biologics License Applications (BLAs) • Thirty-six (36) months after publication of the final guidance: All original commercial Investigational New Drug Applications (INDs)

The Organisation for Professionals in Regulatory Affairs