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Final Rules Medical Research

Gardner Law

LDT Rule Vacated: FDA Backs Down, but Uncertainty Remains

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In December 2024, we published an alert highlighting the FDA’s final rule on Laboratory Developed Tests (LDTs) and the compliance countdown to May 2025. The rule, issued in May 2024, sought to phase out the agency’s...more

Lathrop GPM

Flying Through the Whirlwind: Health Care Industry Continues To Be Buffeted as Administration Rolls Out New Initiatives

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Health care providers and payers have been subject to a flurry of developments at the federal level in recent weeks. Considering that health care represents almost 18% of the U.S. gross domestic product, this was perhaps...more

Holland & Knight LLP

HHS OHRP Amends Protections of Human Research Subjects Rule for Specified Populations

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The Office for Human Research Protections (OHRP) of the U.S. Department of Health and Human Services on Oct. 25, 2024, issued nonsubstantive amendments to subparts B, C and D of 45 CFR Part 46, which provide additional...more

K&L Gates LLP

Long-Awaited Changes to Research Misconduct Rules Have Arrived

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On 12 September 2024, the Office of Research Integrity (ORI) within the US Department of Health and Human Services (HHS) issued a final rule (Final Rule) that significantly modified the standards, procedures, and requirements...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in the Fourth Quarter of 2024 and Beyond

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As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape....more

Venable LLP

FDA to Study Presence of Metals in Tampons: What to Know

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On September 10, the Food and Drug Administration (FDA) Biocompatibility and Toxicology Program published a statement announcing its intention to commission an independent literature review and internal bench laboratory study...more

Holland & Knight LLP

HHS Announces Updates to Policies on Research Misconduct

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The 2024 Public Health Service (PHS) Policies on Research Misconduct involving PHS-funded research were released by the U.S. Department of Health and Human Services (HHS) through the Office of Research Integrity (ORI) on...more

Health Care Compliance Association (HCCA)

Final Rule Increases Fines for Grant Fraud, Codifies OIG Authority to Sanction Awardees

Report on Research Compliance Volume 20, no 8 (August 2023) With the publication of a rule finalizing financial penalties for grant fraud and related violations of U.S. law, the HHS Office of Inspector General (OIG) has a...more

Verrill

Tag, You’re It: FDA Issues Guidance Ahead of Revisions to its Human Subjects Protection Regulations

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Earlier this month, the U.S. Food and Drug Administration (“FDA”) issued new guidance (“Guidance”) for sponsors, investigators, and institutional review boards (“IRBs”) regarding how recent changes to the Federal Policy for...more

Bergeson & Campbell, P.C.

EPA Issues Final Rule Delaying Compliance Date for Human Subjects Policy by Six Months; Institutions May Utilize Three...

On June 19, 2018, sixteen federal agencies, including the U.S. Environmental Protection Agency (EPA), issued a final rule delaying until January 21, 2019, the general compliance date for 2017 revisions to the policy governing...more

Cozen O'Connor

The Legality of Cannabidiol and Concerns Regarding False Advertising

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The legality of marijuana (also known as cannabis) has been a popular topic in recent years with thirty states and the District of Columbia having laws that legalize marijuana in some form. However, under federal law,...more

Nelson Mullins Riley & Scarborough LLP

A Framework for Readying Your Institution for Complying With the Revised Common Rule

Earlier this year, the long-awaited revision to the Federal Policy for the Protection of Human Subjects, known as the ‘‘Common Rule,’’ was published in the Federal Register (the ‘‘Final Rule’’). 82 Fed. Reg. 7149 (Jan. 19,...more

Shumaker, Loop & Kendrick, LLP

Client Alert: U.S. Department of Health and Human Services ("HHS") Delays Effective and Compliance Date for the Revised Common...

The Federal Policy for the Protection of Human Subjects, or the “Common Rule,” was originally published in 1991 and has been adopted and codified in separate regulations by HHS and 15 other federal departments and agencies. ...more

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