Comment from Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital
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Summary: The Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital, representing an academic institution, supports the draft guidance but requests specific modifications to improve its practical application. They argue for language that acknowledges the balance between statistical risks and operational feasibility, specifically advocating for a two-step informed consent process and more flexibility for rare disease studies.
Please see attached comments on Docket ID: FDA-2023-D-5259 from the Sean M. Healey and AMG Center at Massachusetts General Hospital