Former FDA Officials Discuss the Far-Reaching Effects of RWD During the COVID-19 Pandemic

Amy Abernethy, former deputy principal commissioner at the Food and Drug Administration (FDA), discussed the impact of the COVID-19 pandemic on the use of real world data (RWD). Abernethy, along with two other former FDA officials, note the widespread use of RWD to speed up approval of novel therapies. However, its role in regulatory applications is expected to diminish.

Abernethy remarks, “What’s going to happen is the regulatory agencies are required to essentially go back to the way it was before,” adding, “But we don’t unlearn.” Read more here.

(Source: Katie Palmer, STAT News, 8/10/21)