Emerging Technology Integration in FDA’s Drug Approval Process

• 18 June 2018
• By Monika Jain, PhD Shilpa Rana 

This article discusses important aspects of the US Food and Drug Administration’s (FDA’s) “Emerging Technology Program” with a focus on emerging technology, such as continuous manufacturing and 3D printing, and details what information is to be included in drug submissions. The authors highlight a number of benefits of the program, including the synergy created between FDA and the pharmaceutical industry.