This regular CTIS newsflash provides key updates on CTIS and links to useful reference materials.
Set for launch later in 2023, the Innovative Devices Access Pathway (IDAP) will be run by the MHRA, NICE, and other partners, including the devolved administrations.
MHRA announces new recognition routes to facilitate safe access to new medicines with seven international partners
Andrew Fisher, Lead Senior GCP Inspector, writes a blog about the recent changes.
CVMP opinions on veterinary medicinal products
This guidance describes FDA’s current recommendations regarding adjusting for covariates in the statistical analysis of randomized clinical trials in drug2 development programs. This guidance provides recommendations for the use of covariates in the analysis of randomized, parallel group clinical trials that are applicable to both superiority trials and noninferiority trials.
As FDA considers the application of its risk-based regulatory framework to the use of AI technologies in drug manufacturing, the Agency has identified in this discussion paper areas for which public feedback would be valuable.
The FDA have published two Guidance Snapshots accompanied by two Guidance Recap Podcasts to highlight the agency’s commitment to improve the diversity of participants in clinical trials, and to increase awareness of the agency’s 2020 guidance, Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs, which presents recommendations sponsors can apply to diversify participation in clinical trials.
Today (24th May) at the World Health Organization (WHO), panelists made an impassioned plea for urgent climate action as it hosted a Strategic Roundtable on the Role of the Health Communities in Climate Action: taking stock and moving forward at the World Health Assembly.
ICH-E6(R3): An Important Global Good Clinical Practice Standards - Available for Public Input.