To amend the Federal Food, Drug, and Cosmetic Act with respect to postapproval study requirements for certain controlled substances, and for other purposes.
Health, Education, Labor, and Pensions Committee, Energy and Commerce Committee
Introduced
In Committee
On Floor
Passed Chamber
Enacted
Long-Term Opioid Efficacy Act of 2018 This bill expands the authority of the Food and Drug Administration (FDA) to require post-approval studies or clinical trials with respect to controlled substances (e.g., opioids).
Drug safety, medical device, and laboratory regulationDrug trafficking and controlled substancesLicensing and registrationsPrescription drugs
To amend the Federal Food, Drug, and Cosmetic Act with respect to postapproval study requirements for certain controlled substances, and for other purposes.
USA115th CongressHR-5811| House
| Updated: 6/20/2018
Long-Term Opioid Efficacy Act of 2018 This bill expands the authority of the Food and Drug Administration (FDA) to require post-approval studies or clinical trials with respect to controlled substances (e.g., opioids).