3.0.0 1634 2023-01-11T13:50:13Z 2023-01-11T13:50:13Z Senate S 2021-05-13 117 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2021-05-13T20:14:30Z 2021-05-13 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2021-05-13 Introduced in Senate IntroReferral 10000 9 Library of Congress M001183 Sen. Manchin, Joe, III [D-WV] Joseph Manchin D WV N B001310 Sen. Braun, Mike [R-IN] Mike Braun R IN 2021-05-13 True Health Advisory bodies Department of Health and Human Services Drug safety, medical device, and laboratory regulation Drug trafficking and controlled substances Drug, alcohol, tobacco use Food and Drug Administration (FDA) Government studies and investigations Medical research Health 00 2021-05-13 Introduced in Senate 2021-10-28T11:06:00Z FDA Review of Efficacy of EERW Double-Blinds of Opioids Act or the FREED of Opioids Act

This bill requires the Food and Drug Administration (FDA) to take certain actions to determine whether to permit the use of a certain methodology for drug clinical trials.

Specifically, the FDA must seek to contract with the National Academy of Sciences (NAS) for the NAS to conduct a study on the effectiveness of using enriched enrollment randomized withdrawal methodology in demonstrating the efficacy of opioid drugs in treating chronic pain.

The FDA must also convene a meeting of two specified FDA advisory committees to review the NAS study and vote on whether to permit the use of this methodology in drug clinical trials.

]]> FREED of Opioids Act Display Title FREED of Opioids Act Official Title as Introduced A bill to require the Food and Drug Administration to determine whether to permit the use of enriched enrollment randomized withdrawal methodology with respect to clinical trials. Introduced in Senate IS Short Title(s) as Introduced FREED of Opioids Act Introduced in Senate IS Short Title(s) as Introduced FDA Review of Efficacy of EERW Double-Blinds of Opioids Act Introduced in Senate IS Introduced in Senate 2021-05-13T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-117s1634is/xml/BILLS-117s1634is.xml 2021-05-13 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.