An interim independent assessment of the WHO’s response to the COVID-19 pandemic has supported the organization’s work. But will be it enough to convince critics as the WHO faces the threat of permanently losing funds from its biggest donor, the US?
An independent interim review of the World Health Organization’s handling of the coronavirus pandemic has concluded that the organization “demonstrated leadership” and made important progress in its COVID-19 response “considering the novel nature of this virus and persistent unknown factors.”
The review found that the “virus was sequenced with great speed” and that the WHO Health Emergencies (WHE) program had...
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
To help sponsors developing candidate mpox vaccines, the World Health Organization will soon be finalizing guidance on the preferred and minimum characteristics these products must satisfy regarding efficacy, dose regimen and other aspects to secure regulatory approval.
The WHO’s emergency committee has warned of a lack of understanding of the epidemiology of mpox, the limited availability of vaccines, and the complexities of donations and procurement.
An ongoing collaborative initiative involving global regulators assessing post-approval manufacturing changes has highlighted the need to establish a standardized platform that can facilitate the submission and regulatory evaluation of such changes.
A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.
With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.
