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Articles on FDA approval process

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Regulations in the US and EU are intended to ensure that cosmetics and other personal-care products are safe, but the two continents approach the issue in different ways. Marco Verch/Flickr

Just how safe are cosmetics on the European market?

From miscarriages to cancer, poor regulation of cosmetics in the US have taken a devastating toll on consumers’ lives. Are European consumers any safer?
Millions of U.S. children ages 5-11 have already received at least one dose of the COVID-19 vaccine. Keith Birmingham/MediaNews Group/Pasadena Star-News via Getty Images

COVID-19 vaccines for the youngest children may be inching closer to authorization – a pediatrician explains how they’re being tested

Moderna will ask the FDA to allow emergency use for its vaccine in children as young as 6 months, a step many parents have been anticipating.
Research suggests that about 20% of all prescriptions are administered “off-label.” Hafakot/iStock via Getty Images Plus

Off-label’ use is common in medicine – a bioethicist and legal philosopher explain why the COVID-19 vaccines are different

The CDC’s COVID-19 vaccine provider agreement prohibits health care professionals from administering the vaccines in people for whom they are not yet authorized or approved. But this departs from longstanding norms.
Carter Giglio, 8, joined by service dog Barney of Hero Dogs, shows off the bandage over his injection site after being vaccinated at Children’s National Hospital in Washington. (AP Photo/Carolyn Kaster)

I’m an infectious disease doctor. Yes, I’m vaccinating our 5-year-old against COVID-19. Here is why you should too.

An infectious diseases doctor reviews the evidence, discusses hesitancy and concerns about side-effects and explains the overwhelming case for vaccinating five-to-11-year-olds, including his own son.
Ethics are important to vaccination decisions because while science can clarify some of the costs and benefits, it cannot tell us which costs and benefits matter most to us. THE CANADIAN PRESS/Frank Gunn

Ethical decisions: Weighing risks and benefits of approving COVID-19 vaccination in children ages 5-11

When making the decision whether to vaccinate children aged five to 11 against COVID-19, regulators in Canada must rely on sound ethics as well as sound science.
Pregnancy poses significant risks for severe illness or death from COVID-19, for both mother and baby. ArtMarie/E+ via Getty Images

Vaccination against COVID-19 supports a healthy pregnancy by protecting both mother and child – an immunologist explains the maternal immune response

In light of mounting research showing the serious risks of contracting COVID-19 during pregnancy, the CDC is re-upping its urgency that pregnant women get their shots.
Protesters gather at Indiana University in June 2021 to demonstrate against mandatory COVID-19 vaccinations for students, staff and faculty. SOPA Images/LightRocket via Getty Images

Forceful vaccine messages backfire with holdouts – how can it be done better?

Subtly shifting the crafting and delivery of public health messaging on COVID-19 vaccines could go a long way toward persuading many of the unvaccinated to get the shot.
FDA approval of Pfizer’s COVID-19 vaccine may boost vaccination rates among those who have been hesitant to get the shot. (AP Photo/Jessica Hill)

Pfizer’s COVID-19 vaccine now has full FDA approval. Here’s what that means for unvaccinated people, organizations and pharma

The U.S. FDA has approved the first COVID-19 vaccine. How is approval different from emergency use authorization, and what difference will it make to a vaccine that’s already in global use?
Though drug recalls are relatively uncommon in the U.S., reduced inspections increase the likelihood of manufacturing errors that slip through the cracks. AP Photo/Rafiq Maqbool

The FDA’s weak drug manufacturing oversight is a potentially deadly problem

COVID-19 has exacerbated a backlog of domestic and foreign drug manufacturing inspections that the FDA is still too short-staffed to adequately deal with.
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.
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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