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Ethics › Department of Health and Human Services (HHS) › Food and Drug Administration (FDA)

Foley & Lardner LLP

FDA & OHRP Draft Guidance: Including Tissue Biopsies in Clinical Trials

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The U.S. Food and Drug Administration (FDA), and the Office of Human Research protections (OHRP) released draft guidance titled, “Considerations for Including Tissue Biopsies in Clinical Trials.” Although non-binding, the...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: August 2024

Health Care Compliance Association (HCCA) on

The Food and Drug Administration (FDA) has given Massachusetts Institute of Technology (MIT) 15 days from receipt of its June 21 warning letter to elaborate on corrective actions to address violations of federal requirements...more

Bass, Berry & Sims PLC

OHRP Releases Guidance for Institutions Conducting Human Subjects Research During COVID-19

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The Office for Human Research Protections (OHRP) released guidance earlier this week in response to the COVID-19 pandemic, encouraging researchers to prioritize public health and safety. The guidance clarifies how the...more

Health Care Compliance Association (HCCA)

Report on Research Compliance 17, no. 1. In This Month's E-News: January 2020

Health Care Compliance Association (HCCA) on

Report on Research Compliance 17, no. 1 (January 2020) - ? A man from Richland, Washington, is facing life in prison after being convicted of 47 counts of fraud for staging clinical trials that purportedly enrolled dozens of...more

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