3.0.0 1048 2023-01-11T13:36:30Z 2023-01-11T13:36:30Z Senate S 2017-05-04 115 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2017-05-04T18:13:33Z FDA Reauthorization Act of 2017 115 934 S 2017-05-11 Placed on Senate Legislative Calendar under General Orders. Calendar No. 76. Related bill CRS FDA Reauthorization Act of 2017 115 2430 HR 2017-08-18 Signed by President. Related bill CRS 2017-05-04 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2017-05-04 Introduced in Senate IntroReferral 10000 9 Library of Congress H000338 Sen. Hatch, Orrin G. [R-UT] ORRIN HATCH R UT GRANT N B001267 Sen. Bennet, Michael F. [D-CO] Michael Bennet D CO 2017-05-04 True B001135 Sen. Burr, Richard [R-NC] Richard Burr R NC Mauze 2017-05-04 True C001070 Sen. Casey, Robert P., Jr. [D-PA] Bob Casey D PA 2017-05-04 True Health Administrative law and regulatory procedures Congressional oversight Department of Health and Human Services Drug safety, medical device, and laboratory regulation Drug therapy Food and Drug Administration (FDA) Government studies and investigations Medical research Public participation and lobbying Health 00 2017-05-04 Introduced in Senate 2018-01-17T19:34:37Z Enhanced Clinical Trial Design Act of 2017

This bill requires the Food and Drug Administration (FDA), in coordination with the National Institutes of Health, to convene a meeting to discuss clinical trial inclusion and exclusion criteria. The FDA must report on the meeting and issue guidance regarding eligibility criteria for clinical trials.

The Government Accountability Office must report on individual access to investigational drugs for serious conditions through the FDA's expanded access program (i.e., compassionate use).

The FDA must streamline review by institutional review boards of expanded access protocols for individual patients.

The bill amends the Federal Food, Drug, and Cosmetic Act to require the manufacturer or distributor of an investigational drug for a serious condition that is designated a breakthrough therapy, fast track product, or regenerative advanced therapy to publish its expanded access policy not later than 15 days after the designation.]]> Enhanced Clinical Trial Design Act of 2017 Display Title Enhanced Clinical Trial Design Act of 2017 Official Title as Introduced A bill to expand patient access to experimental treatments in clinical trials, and for other purposes. Introduced in Senate IS Short Titles as Introduced Enhanced Clinical Trial Design Act of 2017 Introduced in Senate 2017-05-04T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-115s1048is/xml/BILLS-115s1048is.xml 2017-05-04 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.