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Articles on FDA

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Alzheimer’s disease is characterized by progressive memory loss, spatial disorientation and many other cognitive and behavioural disorders that ultimately lead to a state of total dependence. (Shutterstock)

FDA approval of controversial Alzheimer’s drug could delay discovery of more promising treatments

The new drug is based on the idea that a build-up of amyloid in the brain leads to the disease. But that hypothesis has been under scrutiny lately.
Do the benefits of approving a drug before confirming it works outweigh the potential costs? monkeybusinessimages/iStock via Getty Images Plus

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.
Exterior of the Pfizer World headquarters building. Pfizer produced the first COVID-19 vaccine to gain emergency use authorization. Sam Aronov/Pacific Press/LightRocket via Getty Images

Why is the FDA funded in part by the companies it regulates?

The FDA receives almost half its funding from companies it regulates, such as drug and medical device makers. Is this something you should be concerned about?
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.
The new rapid test is available without a prescription, but only 20 million are set to be sold by the middle of next year. Ellume/AP

FDA authorized first over-the-counter COVID-19 test – useful but not a game changer

A new over-the-counter COVID-19 test has been authorized by the FDA. Though it can be used to test people with and without symptoms, moderate cost and limited production mean it isn’t a game-changer.
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?

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