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Expert Analysis

Ruling In HHS Case May Mean More Drug Trial Reporting

By Christina Markus, Beverly Lorell, Ashley Parrish, Elaine Tseng and Jeffrey Bucholtz (March 19, 2020, 5:25 PM EDT) -- Section 801 of the U.S. Food and Drug Administration Amendments Act of 2007 (codified at 42 U.S.C. § 282(j)) requires that sponsors of applicable clinical trials, or ACTs, register those trials and submit "basic results" specified in the statute to the public ClinicalTrials.gov data bank....

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