As a result, the U.S. government has taken increased measures with the passage of the Food and Drug Omnibus Report Act of 2022 (FDORA), which will require sponsors to submit diversity plans to the U.S. Food and Drug Administration (FDA) for all late-stage st…
Unraveling the impact of FDORA and PREVENT Pandemics Acts on the life sciences
In a recent interview, life sciences attorney Barbara Binzak Blumenfeld offers insights into significant recent legislative, judicial, and regulatory developments, including the planned end to the COVID-19 Public Health Emergency (PHE), the enactment of the Food and Drug Omnibus Reform Act (FDORA), and the Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act (PREVENT Pandemics Act).
With a Ph.D. in molecular biology, Blumenfeld is well-versed in the scientific, ethical, and legal issues that are pivotal in the life sciences. In a recent interview, she touched on the expiration of the COVID-19 Public Health…