Conducting Clinical Trials With Decentralized Elements
The FDA has issued final Level 1 guidance (Docket Number: FDA-2022-D-2870) from the Center for Drug Evaluation and Research, the Center for …
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FDA Qualifies Apple Watch AFib History Feature as a New…
On May 1, 2024, the FDA made a significant announcement by qualifying the Apple Watch AFib History Feature as a biomarker test device throug…
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Thai FDA’s Proposed Draft Notification: Annual Sa…
Thai FDA proposes a draft Notification mandating annual safety reports for terminated or completed clinical research, aligning with Herbal P…
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US FDA Eases Informed Consent for Minimal Risk Clinical…
FDA Implements 21st Century Cures Act: Effective 30 days post-publication, ensuring rights and safety of human subjects. The final rule amen…
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FDA Proposes Human Abuse Potential Study for Kratom
FDA allocates $2 million for institutions conducting a Human Abuse Potential (HAP) study on botanical Kratom due to rising concerns over its…
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ANVISA Published Regulation For Medical Devices
ANVISA issued Resolution 837/2023 on December 15, outlining updated procedures for clinical investigations supporting higher-risk Medical De…
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