3.0.0 2665 2023-01-11T13:39:42Z 2023-01-11T13:39:42Z Senate S 2018-04-12 115 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2018-04-12T20:39:20Z Opioid Crisis Response Act of 2018 115 2680 S 2018-05-07 Placed on Senate Legislative Calendar under General Orders. Calendar No. 398. Related bill CRS 2018-04-12 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2018-04-12 Introduced in Senate IntroReferral 10000 9 Library of Congress Y000064 Sen. Young, Todd [R-IN] Todd Young R IN C. N D000607 Sen. Donnelly, Joe [D-IN] Joe Donnelly D IN 2018-04-12 True Health Administrative law and regulatory procedures 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 information and archives Health information and medical records Medical ethics Prescription drugs Health 00 2018-04-12 Introduced in Senate 2019-08-20T17:16:46Z This bill requires the Food and Drug Administration (FDA)to develop guidance regarding how it will assess evidence to support claims of opioid sparing (i.e., the use of drugs that reduce pain while also allowing reduced use or avoidance of oral opioids) for non-opioid or other non-addictive medical products intended to treat pain.

The FDA must also develop guidance regarding how it will consider the misuse and abuse of drugs in making certain determinations of safety.

]]> A bill to require guidance on how the Food and Drug Administration will consider claims of opioid sparing and on the conditions under which the Food and Drug Administration will consider misuse and abuse of drugs in making certain determinations of safety. Display Title A bill to require guidance on how the Food and Drug Administration will consider claims of opioid sparing and on the conditions under which the Food and Drug Administration will consider misuse and abuse of drugs in making certain determinations of safety. Official Title as Introduced A bill to require guidance on how the Food and Drug Administration will consider claims of opioid sparing and on the conditions under which the Food and Drug Administration will consider misuse and abuse of drugs in making certain determinations of safety. Introduced in Senate IS Introduced in Senate 2018-04-12T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-115s2665is/xml/BILLS-115s2665is.xml 2018-04-12 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.