The International Coalition of Medicines Regulatory Authorities have sketched out the criteria that should be met before candidate coronavirus vaccines can proceed into late-stage trials, and agreed on how to design the studies and who should be included.
Phase III trials of potential COVID-19 vaccines should have “stringent success criteria” for establishing efficacy in order to rule out the approval of “weakly effective vaccines that could do more harm than good,” says a group of international drug regulators.
The regulators also say that Phase III trials should have standardized endpoints, include diverse populations and have at least one...
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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
