News Archive

FDA - Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products Guidance for Industry

25th May 2023

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.

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FDA - Discussion Paper: Artificial Intelligence in Drug Manufacturing

25th May 2023

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.

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FDA - Guidance Snapshots/Podcasts highlight the agency’s commitment to improve the diversity of participants in clinical trials

25th May 2023

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.

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WHO - WHO issues urgent call for global climate action to create resilient and sustainable health systems

25th May 2023

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.

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ICH - ICH E6(R3) Principles, Annex 1 and Annex 2

23rd May 2023

ICH-E6(R3): An Important Global Good Clinical Practice Standards - Available for Public Input.

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EMA - Annual report 2022 published

17th May 2023

EMA published its annual report 2022 on 15th May 2023. The report provides an overview of the Agency’s activities to protect and promote public and animal health in the European Union (EU).

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EMA - 3-year work plan for the Quality domain

17th May 2023

The GMDP IWG 3-year workplan is developed with a focus on the Network Strategy and Regulatory Science Strategy (RSS) goals, with a particular emphasis on supply chain integrity and resilience, product quality and the impact of new manufacturing technologies on the supply chain.

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