FDA's RWE Grantees: One Year On

1:00 PM - 2:00 PM (PDT), Monday, June 13, 2022 ・ Upper Level, Session Room 5A

In late 2020, FDA announced that it had awarded four grants to researchers to examine the use of real-world data (RWD) to generate RWE in regulatory decision-making. Through these grants, FDA seeks to further assess potential study designs and analytic methodologies to determine whether observational studies can reliably generate evidence on the safety and effectiveness of drugs to support regulatory decisions. Our interactive panel will give a brief introduction to the grantees and their unique projects, explore the impact of different settings, patient populations, and data-gathering approaches, and, most importantly, share insights gained about whether particular models are more likely to garner acceptance from FDA in the near term.

Moderators
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Of Counsel
Morrison & Foerster LLP
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COO
Tempus