News & Analysis as of

Final Rules Clinical Trials

Proskauer - Health Care Law Brief

OIG Reports that Clinical Trials Lack Diverse Subjects: What Role Can Artificial Intelligence Play?

As the largest public funder of biomedical research in the world, the National Institutes of Health (“NIH”) annually funds over $38 billion in extramural research, including about $6 billion for clinical trials. On May 28,...more

Goodwin

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

Goodwin on

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

McGuireWoods Consulting

Washington Healthcare Update - July 2024

This Week in Washington: House Ways and Means Committee marks up healthcare bills related to new technologies and coverage for weight loss drugs; CMS releases CY2025 Home Health and End-Stage Renal Disease PPS proposed rules;...more

Morgan Lewis

Key Takeaways from FDA’s Final Rule on Laboratory-Developed Tests

Morgan Lewis on

The US Food and Drug Administration (FDA) on April 29, 2024 announced its Final Rule on laboratory-developed tests (LDTs). This marks the beginning of the end of FDA’s broad and long-established enforcement discretion policy...more

Hogan Lovells

FDA under fire: Pared-down LDT Final Rule leaves unanswered questions

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The U.S. Food and Drug Administration (FDA) has finalized its historic — and notoriously controversial — rule to explicitly assert the agency’s authority to regulate laboratory developed tests (LDTs). Below we summarize the...more

ArentFox Schiff

As the (Customs and Trade) World Turns - April 2024

ArentFox Schiff on

Welcome to the April 2024 issue of “As the (Customs and Trade) World Turns,” our monthly newsletter where we compile essential updates from the customs and trade world over the past month. We bring you the most recent and...more

Jones Day

FDA Final Rule: IRB Waiver of Informed Consent for Minimal-Risk Investigations

Jones Day on

The Food and Drug Administration ("FDA") expands informed consent exceptions with a final rule permitting institutional review board ("IRB") waiver or alteration of elements for certain FDA-regulated minimal-risk clinical...more

Hogan Lovells

FDA permits IRB informed consent waivers for minimal risk clinical trials

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) has published a final rule on “Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations,” which permits an exception from the...more

McGuireWoods Consulting

Washington Healthcare Update - December 2023 #2

McGuireWoods Consulting on

This Week in Washington: House Energy and Commerce Committee markup includes 19 healthcare bills; Senate HELP Committee to mark up SUPPORT Act Reauthorization and three other bills; House to vote on Lower Costs, More...more

King & Spalding

FDA Issues New Draft Guidance for Sponsors on Safety Event Analysis and Reporting for IND and Bioavailability/Bioequivalence...

King & Spalding on

Focuses on Aggregate Safety Data Analysis and Expedited Reports; Expectation for Prospective Safety Surveillance Plan - The Food and Drug Administration (FDA) has issued a new draft guidance (the Draft Guidance) that...more

Mintz - Health Care Viewpoints

With Release of New Guidance, FDA Signals It’s Serious About Enforcing Clinical Trial Data Requirements

Clinical trial sponsors and principal investigators can consider themselves on notice that the Food & Drug Administration (FDA) is poised to ramp up enforcement activity relating to responsible parties’ obligations regarding...more

Mintz - Health Care Viewpoints

Clinical Trial Results Will See Daylight After HHS Final Rule Is Set Aside

Some clinical trial sponsors and principal investigators will be digging through their archives soon as a result of a recent ruling in the case of Seife v. U.S. Department of Health and Human Services, case number...more

King & Spalding

U.S. District Court Overturns HHS Interpretation of Final Rule that Permitted Sponsors of Certain Drug and Device Trials to Avoid...

King & Spalding on

If Sustained, Court Decision Will Require Disclosure of Results for a Decade of Certain Clinical Trials - Section 801 of the Food and Drug Administration Amendments Act of 2007 (“Section 801”), which is codified at 42...more

Foley & Lardner LLP

FDA’s Response to HHS’ Revised Common Rule: Four Things to Know

Foley & Lardner LLP on

In a final rule published on January 19, 2017, HHS and several federal departments and agencies made revisions to the Common Rule, the federal policy for the protection of human subjects applicable to human subject research...more

Verrill

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

Verrill on

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

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

Arnall Golden Gregory LLP

HHS Issues Final Revisions to the Common Rule – New Protections for Human Research Subjects

On January 19, 2017, the U.S. Department of Health and Human Services (HHS) and fifteen other Federal Departments and Agencies issued a final rule to update “Federal Policy for the Protection of Human Subjects,” also known as...more

Hogan Lovells

HHS Overhauls the Common Rule to Enhance Protection for Human Subjects in Research

Hogan Lovells on

On 18 January 2017, as one of the last actions of the outgoing Obama Administration, the U.S. Department of Health and Human Services (HHS) and fifteen other federal agencies (the Agencies) issued a final rule overhauling the...more

BakerHostetler

Welcome to the Future: HHS Releases Final Rule to Modernize Protections for Clinical Trial Participants

BakerHostetler on

The Federal Policy for the Protection of Human Subjects, or the “Common Rule,” governs the ethical conduct of research involving human subjects and is funded through various federal agencies. On January 19, the U.S....more

Bergeson & Campbell, P.C.

Federal Agencies Announce Revision to Modernize Federal Policy for the Protection of Human Subjects

On January 19, 2017, the U.S. Environmental Protection Agency (EPA), together with a host of other federal agencies, announced revisions via a final rule to modernize, strengthen, and make more effective the Federal Policy...more

Polsinelli

New Clinical Trial Rule Alters Reporting Requirements

Polsinelli on

New federal requirements for posting of clinical trials information address how data collected in clinical trials are submitted for public consumption. The requirements were revealed on Sept. 16 when the Department of Health...more

King & Spalding

HHS Issues Final Rule that Expands the Requirements for Disclosure of Clinical Trial Data to ClinicalTrials.gov

King & Spalding on

On September 21, 2016, the Department of Health and Human Services (HHS) published a final rule that greatly expands the information that sponsors of “applicable drug clinical trials” and “applicable device clinical trials”...more

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