When the IRB approves a project/package with conditions or defers IRB review, the Principal Investigator (PI) must submit the requested changes/revisions in a timely manner (e.g., within 30 days).
On July 9, 2019, the U.S. Food & Drug Administration (FDA) released the final guidance document “Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry,” which ...
On June 9, 2020, at its monthly open meeting and by a 3-2 vote, the Federal Communications Commission (FCC) adopted a Declaratory Ruling and Notice of Proposed Rulemaking clarifying certain aspects of ...
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