The FDA's lax oversight of research in developing countries can do harm to vulnerable participants

Regulatory loopholes for research conducted off US soil allow for questionable trials and misleading data to slip under the FDA’s radar.

C. Michael White, Distinguished Professor and Head of the Department of Pharmacy Practice, University of Connecticut • conversation
Nov. 12, 2021 • ~5 min

What does full FDA approval of a vaccine do if it's already authorized for emergency use?

While emergency use authorization gets vaccines out to the public more quickly, it doesn’t skip any steps that full approval requires.

Jennifer Girotto, Associate Clinical Professor of Pharmacy Practice, University of Connecticut • conversation
Aug. 11, 2021 • ~5 min

The FDA's big gamble on the new Alzheimer's drug

The FDA approved Alzheimer's disease drug aducanumab despite minimal evidence of its efficacy. Whether this decision ultimately hurts or helps patients depends on data researchers don't yet have.

C. Michael White, Distinguished Professor and Head of the Department of Pharmacy Practice, University of Connecticut • conversation
June 10, 2021 • ~10 min

What are emergency use authorizations, and do they guarantee that a vaccine or drug is safe?

The vaccines that will first be used to prevent the spread of COVID-19 will have gone through a special approval process with the FDA. but just what is this expedited process?

Jeremy Greene, Professor of Medicine, Johns Hopkins University • conversation
Dec. 3, 2020 • ~10 min

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