Pharma companies seeking a subscription-style contract for new antimicrobials will need to meet a number of requirements, such as guaranteeing surety of supply, meeting key performance measures and complying with specified manufacturing standards.
New antimicrobials that target any of the three “critical” infectious agents on the World Health Organization’s priority pathogen list are among the products that will be eligible for a subscription-style contract with the National Health Service in the UK, according to guidance issued by NHS England.
Companies seeking a contract for a new antimicrobial agent will also have to commit to ensuring supply of the product...
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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
