The pharma industry warned that if proposed new prescription price guidelines go ahead, drug launches would be delayed and ‘Canadian patients will be deprived of potentially life-saving new medicines.’
The pharma industry claims lower prescription drug prices will mean less access to new medication for Canadians. It’s an old threat that pits profits against patients’ rights to affordable drugs.
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.
From miscarriages to cancer, poor regulation of cosmetics in the US have taken a devastating toll on consumers’ lives. Are European consumers any safer?
Tainted dietary supplements could lead to harmful drug interactions.
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Products aimed at sexual dysfunction and weight loss were the most common dietary supplements that contained hidden – and potentially harmful – ingredients.
Millions of U.S. children ages 5-11 have already received at least one dose of the COVID-19 vaccine.
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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.”
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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.
Nearly 80% of participants in FDA-reviewed research trials live in foreign countries.
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Regulatory loopholes for research conducted off US soil allow for questionable trials and misleading data to slip under the FDA’s radar.
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)
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.
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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.
Ceci n'est pas un Magritte.
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Three tobacco-flavored cartridges and a vaping device have been approved by the FDA for sale in the US. It comes after a decadelong debate over e-cigarettes.
Pregnancy poses significant risks for severe illness or death from COVID-19, for both mother and baby.
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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.
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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.
Rapid antigen COVID-19 tests, designed for use at home, can show results in 15 minutes.
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Making rapid antigen tests for COVID-19 cheaper and more accessible can catch the infectious cases before they spread and help everyone resume normal activities safely.
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)
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?
Full FDA approval of the COVID-19 vaccines may help people feel more secure in its safety and effectiveness.
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While emergency use authorization gets vaccines out to the public more quickly, it doesn’t skip any steps that full approval requires.
Aducanumab (Aduhelm) was approved in the U.S., but there is no convincing evidence the drug will help Alzheimer’s patients.
FDA approval of aducanumab (Aduhelm) was contentious. Its submission to Health Canada for approval highlights concerns about evidence, independence and transparency in Canada’s drug approval process.
Though drug recalls are relatively uncommon in the U.S., reduced inspections increase the likelihood of manufacturing errors that slip through the cracks.
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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.
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?
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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.
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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)
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.