The U.S. Food and Drug Administration (FDA) issued a Notice of Proposed Rulemaking (NPRM) in the Federal Register November 15, 2018 entitled, “Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations.” The NPRM seeks to amend regulations 21 CFR Parts 50, 312, and 812 in alignment with provisions in the 21st Century Cures Act (Cures Act). Our previous blog details the proposed rule.
Public comments can be made here. In response to a request for additional time for public comments, the deadline has been extended to February 13, 2019.
- The Clinical Pathways Team
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