Hiiti Sillo, director of the WHO’s office for regulation and safety, told an audience at this year’s IMDRF meeting in Seattle that WHO is putting the finishing touches on a streamlined product application dossier process, one of several work products that should be ready for publication sometime in 2025.
Shares of Chinese and South Korean med-tech companies continued to rise after the World Health Organization declared mpox a public health emergency of international concern Aug. 14 after recent outbreaks.
COVID-19 is the unwanted gift that keeps on giving. The U.S. CDC unwrapped one of those “presents” in a July 12 report that showed the threat of antimicrobial-resistant (AMR) infections has worsened — with resistant hospital-onset infections and deaths in the U.S. each increasing at least 15% during the first year of the pandemic.
While much of the global pandemic response has focused on vaccines, the World Health Organization is now calling on drug manufacturers to ramp up their supply and donations of monoclonal antibodies used to treat COVID-19 infections.
LONDON – The World Health Organization (WHO) is to set up a channel for confidential reporting of illegal, unregistered, unethical or unsafe human genome editing research, as part of a new governance framework it is proposing to develop.
The World Health Organization (WHO) reported a new set of guidelines regarding screening and treatment of cervical cancer, endorsing DNA testing for human papillomavirus (HPV) as the recommended test method.
Although the U.S. CDC considers myocarditis to be a rare event linked to mRNA COVID-19 vaccines, the FDA is adding a warning about the adverse event to its doctor and patient fact sheets for the vaccines.
As COVID-19 deaths across the globe top 3 million, with more than 1 million in Europe alone, the global demand is increasing for mRNA vaccines, even as sponsors of adenovirus vaccines push back against ongoing safety concerns. Last week, the World Health Organization’s (WHO) Regional Office for Europe reported that the confirmed COVID-19 death toll for the region had surpassed 1 million, with 1.6 million new cases being reported every week. More than 171 million doses of COVID-19 vaccines have been administered in the region, translating to nearly 13% of the European population receiving one dose and close to 6% completing both doses of the vaccines.
LONDON – The COVAX initiative, set up in a bid to ensure equitable distribution of COVID-19 vaccines, is poised for a global rollout starting in Q1 2021, after sealing agreements to access 2 billion doses of a number of different products. That puts the world on a clear pathway to ending the acute phase of the pandemic, by protecting the most vulnerable people around the world, according to GAVI, the vaccines alliance, which is spearheading COVAX.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: WHO targets cervical cancer; More time to comment on instituting PTAB trials.
