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Articles sur FDA

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On Dec. 8, 2020, the first members of the public were given doses of a coronavirus vaccine. AP Photo/Frank Augstein, Pool

International Statistic of the Year: Race for a COVID-19 vaccine

The coronavirus vaccine was developed faster than any vaccine in history. It took just 332 days from the first sequencing of the virus genome to the first vaccines given to the public.
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?
Easy, fast coronavirus testing is critical to controlling the virus. AP Photo/Elaine Thompson

Will the new 15-minute COVID-19 test solve US testing problems?

The new BinaxNOW antigen test is quick, easy, accurate and cheap. It could solve the US testing problem, but the emergency use authorization only allows people with COVID-19 symptoms to get tested.
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?
Laboratories around the world are working round the clock to find treatments or a vaccine for COVID-19. Getty Images / Kena Betancur

Could pressure for COVID-19 drugs lead the FDA to lower its standards?

The FDA has sped up its approval process for coronavirus treatments, creating a new division to expedite the regulatory process. But is safety being sidelined for speed?
Employees work on the production line of chloroquine phosphate, resumed after a 15-year break, in a pharmaceutical company in Nantong city in east China’s Jiangsu province Thursday, Feb. 27, 2020. Feature China/Barcroft Media via Getty Images

In the rush to innovate for COVID-19 drugs, sound science is still essential

To battle the coronavirus, strong regulatory protection from the FDA is essential.

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