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Articles on FDA drug approval process

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Tony Potts, a 69-year-old retiree, removes his face mask for a temperature check just before receiving his first injection in a phase 3 COVID-19 vaccine clinical trial sponsored by Moderna. Potts is one of 30,000 participants in the Moderna trial. Paul Hennessy/NurPhoto via Getty ImageS

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?
A lab technician holds a vial of a COVID-19 vaccine candidate during testing at the Chula Vaccine Research Center, run by Chulalongkorn University in Bangkok, Thailand on May 25, 2020. (AP Photo/Sakchai Lalit)

Explainer: How clinical trials test COVID-19 vaccines

Will a vaccine for COVID-19 be safe? Animal testing, human clinical trials and post-approval surveillance give us good grounds to believe that a future approved vaccine will work and be safe.
FDA Commissioner Stephen Hahn, right, and President Trump at a Coronavirus Task Force meeting March 19, 2020. Chip Somodevilla/Getty Images

FDA is departing from long-standing procedures to deal with public health crises, and this may foreshadow problems for COVID-19 vaccines

The rushed emergency approval for a treatment that might help COVID-19 patients has raised questions: Is the FDA abandoning its own guidelines?

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