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Clinical Trials: FDA Publishes Draft Guidance on Diversity Action Plans

On June 26, 2024, the U.S. Food and Drug Administration (FDA) released draft guidance addressing use of diversity action plans (Plans) in the conduct of clinical research entitled “Diversity Action Plans to Improve Enrollment...more

ORI Proposes New Rulemaking for Research Misconduct Regulations

On October 5, 2023, the Office of Research Integrity (ORI) of the Department of Health and Human Services (HHS) issued a notice of proposed rulemaking to update the Public Health Service (PHS) Policies on Research Misconduct...more

Clinical Trials: Consent Process Clarified in New FDA Final Guidance

The U.S. Food & Drug Administration (FDA) issued final guidance (Final Guidance) regarding informed consent titled “Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors” on August...more

COVID-19: Provider Relief Fund General Distribution – Phase 3

On October 1, 2020, the Department of Health and Human Services (HHS) announced a new $20 billion Phase 3 of the Provider Relief Fund (PRF) General Distribution. Much like the Phase 2 funding, Phase 3 funding will be made...more

COVID-19: HHS Publishes Long-awaited Reporting Requirements for Provider Relief Fund Recipients

On September 19, 2020, the Department of Health and Human Services (HHS) released guidance establishing the reporting requirements for health care providers that received Provider Relief Fund (PRF) payments. These reporting...more

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