118-S-607
EFFECTIVE Act
Congress 118Introduced March 1, 2023
Summary
Ensuring the FDA Fully Examines Clinical Trial Impact and Vitalness before Endorsement Act or the EFFECTIVE Act
This bill specifies that the Food and Drug Administration may deny an application for a new opioid analgesic drug (i.e., opioid medication) upon a determination that the drug does not provide a significant advantage with respect to safety or effectiveness as compared to other drugs.