The proposal suggests a rule that would disqualify a life science clinical investigator (e.g, a clinical investigator working in the field of biologics) from working on clinical investigations associated with other life science fields such as pharmaceuticals or medical devices. The rule is designed to protect the subjects of clinical research across the various fields regulated by the FDA. The rule would also allow the FDA to harmonize investigator disqualification regulations across the board.
To learn more about the proposed rule, please feel free to view the extended article.
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