Blog — Clinical Pathways

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Jennifer Lawyer

FDA Releases 3 New Draft Guidances Regarding 510(k) Processes as Part of Modernization Efforts

09/13/2023

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On September 6, 2023 the US Food and Drug Administration (FDA) issued a bulletin announcing three new draft guidances regarding the FDA’s Center for Devices and Radiological Health’s (CDRH) 510(k) premarket submission program to verify that the medical device to be marketed is substantially equivalent to a legally marketed device as medical devices continue to become more complex and innovative.

FDA Informed Consent Final Guidance Finally Here!

08/16/2023

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The US Food and Drug Administration (FDA) published finalized guidance on “Informed Consent” August 2023. It finalized the “Informed Consent Information Sheet” which was previously in draft since July 2014 and supersedes the final guidance “A Guide to Informed Consent” from September 1998. It is applicable for IRBs, investigators, and sponsors.

Advancing Real-World Evidence (RWE) Program FAQ

08/08/2023

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The US Food and Drug Administration (FDA) recently updated their website to include a Frequently Asked Questions page for their Advancing Real-World Evidence (RWE) Program. The Advancing RWE Program was announced in October 2022 and is intended to support new labeling claims, a new indication for an approved drug, or to satisfy post approval requirements.

WHO Issues Draft Guidance on Clinical Trials Best Practices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The World Health Organization (WHO) issued a draft guidance for best practices for clinical trials in July 2023.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.