FDA Warms Up to Real-World Evidence

December 6, 2021

The COVID-19 pandemic has shifted the FDA’s approach to real-world evidence (RWE) in a positive light, according to Stacy Cline Amin, former chief counsel of the FDA. Although the 21st Century Cures Act of 2016 opened the door to implementation of RWE for approval of new indications in previously approved drugs, the agency’s framework and access to RWE was limited. The realities of the pandemic, however, forced a reevaluation of policy.

According to Amin on BioProcess Online, “What I can say from my experience at FDA is that the agency experienced a cultural shift in its willingness to consider and even rely on RWE to inform policy and regulatory decision-making. The agency also undertook huge efforts during that time to improve its access to such data. Those efforts were led by Dr. Amy Abernethy to advance collaborations with public and private partners to collect and analyze a variety of real-world data sources.”

Read the entire article by clicking here.

(Source: BioProcess Online, November 19th, 2021)

Share This Story!