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Department of Health and Human Services (HHS) › Food and Drug Administration Amendments Act (FDAAA) › Final Rules

Goodwin

Health Headlines: July 2025

Goodwin on

Welcome to the sixth issue of Health Headlines, a newsletter created by lawyers in our Healthcare practice....more

Mintz - Health Care Viewpoints

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

Mintz - Health Care Viewpoints on

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...

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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

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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