Regulators’ experiences and two hypothetical case studies form the basis of a set of recommendations on the use of artificial intelligence in areas such as safety signal detection and improving decision making, which have just been published by the International Coalition of Medicines Regulatory Authorities.
A group of international regulators has called for a permanent working group to be set up to discuss the challenges posed by the use of artificial intelligence in medicines regulation and says that guidance might also be needed on the contribution of AI to the development and use of medicines for treatment and diagnosis.
AI tools such as statistical models, algorithms and self-modifying systems are increasingly being employed throughout the drug development pathway, from...
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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
