Article | March 19, 2021

FDA's 2021 Focus Areas Of Regulatory Science: 5 Trends To Watch

By Bikash Chatterjee, CEO, Pharmatech Associates


The pharmaceutical industry has seen more innovation in the last decade than in the past 50 years. The tools we use today to characterize and construct drug therapies, from next-generation gene sequencing technologies to CRISPR/Cas9, give us unprecedented capabilities to identify and treat new disease states. However, these technologies would not have been so influential in the absence of a regulatory framework within which to apply them. The FDA regulates the largest pharmaceutical market in the world and, as such, sets the bar suitably high for drug sponsors to demonstrate safety and efficacy.

In 2020, the FDA recognized that a new approach was required to keep pace with the rapid evolution of science and technology driving drug development, and it released the report Advancing Regulatory Science at FDA: Focus Areas of Regulatory Science (FARS) early in 2021 to identify and communicate areas requiring continued targeted investment. The acronym is apt, as the report is remarkably far reaching. Across the myriad of focus areas of the report’s major FDA Strategic Initiatives, examine five key elements that deserve our attention and provide meaningful regulatory insight on new and emerging approaches to drug development and governance.

access the Article!

Get unlimited access to:

Trend and Thought Leadership Articles
Case Studies & White Papers
Extensive Product Database
Members-Only Premium Content
Welcome Back! Please Log In to Continue. X

Enter your credentials below to log in. Not yet a member of Outsourced Pharma? Subscribe today.

Subscribe to Outsourced Pharma X

Please enter your email address and create a password to access the full content, Or log in to your account to continue.


Subscribe to Outsourced Pharma

Pharmatech Associates - A USP Company