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Department of Health and Human Services (HHS) › Clinical Trials › SACHRP

Health Care Compliance Association (HCCA)

Their Terms Ended by Trump, SACHRP Members Form New Committee, Vow to Continue ‘Mission’

Health Care Compliance Association (HCCA) on

Reflecting thwarted desires to continue their terms, while answering calls from trial administrators and oversight leaders, seven former members of the highest-ranking federal advisory panel on human research...more

Ropes & Gray LLP

Clinical Trial Protocol Deviations: A New FDA Draft Guidance to Ring in the New Year

Ropes & Gray LLP on

As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting protocol deviations in...more

Health Care Compliance Association (HCCA)

FDA Consolidates, Revises Informed Consent Guidance; 2018 Common Rule Not Addressed

Health Care Compliance Association (HCCA) on

Nearly nine years to the day the Food and Drug Administration (FDA) issued a draft “information sheet” on informed consent, the agency published a 66-page final guidance document on the topic—marking the first time since 1998...more

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