Blog — Clinical Pathways

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clinical trials

Implementing the New UK Clinical Trials Regulations

Implementing the New UK Clinical Trials Regulations

01/07/2025

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The Health Research Authority (HRA) announced that England and Wales have begun implementing changes to their clinical trial regulations on June 1st, 2024. These changes include the removal of the requirement for trials to submit annual progress report to their Research Ethics Committee (REC) and the process of submitting safety reports. Scotland and Northern Ireland, following review, also implemented these changes to their regulations making the updates now applicable in all four of the UK nations as of August 1st, 2024.

FDA Looks to Optimize the Processes and Policies of Advisory Committees

FDA Looks to Optimize the Processes and Policies of Advisory Committees

05/14/2024

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On April 29th, 2024 the US Food and Drug administration (FDA) posted a news release outlining an upcoming virtual listening session June 13th, 2024 from 9:00am–4:00pm ET, on the optimal use of and processes for FDA advisory committees (Ad Com). FDA Ad Coms are intended to provide the agency with advice and recommendations from the public as well as external experts from various backgrounds. They review the safety, effectiveness, and appropriate use of products in FDA regulated research by discussing scientific, technical, and policy issues and voting on proposed future actions.

FDA Releases New Draft Guidance on Confirmatory Evidence in Clinical Trials

09/27/2023

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On September 18, 2023, the U.S. Food and Drug Administration (FDA) released a draft guidance titled Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence to provide further detail on the accepted types of confirmatory evidence used to support the results of one adequate and well-controlled clinical investigation.

WHO Issues Draft Guidance on Clinical Trials Best Practices

08/01/2023

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The World Health Organization (WHO) issued a draft guidance for best practices for clinical trials in July 2023. It outlines key scientific and ethical considerations for “good controlled” (also known as well-controlled) trials, guidance on strengthening the clinical trial ecosystem, and addressing underrepresented populations.

When Does the FDA Perform PAIs?

12/05/2022

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Preapproval facility evaluations are conducted by a CDER integrated quality assessment (IQA) team to evaluate if a PAI is needed from a quality perspective before a NDA can be approved. A risk based approach is used with a focus on facility, product, and process.