3.0.0 658 2022-11-01T17:17:27Z 2022-11-01T17:17:27Z Senate S 2019-03-05 116 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2019-03-05T22:22:49Z 2019-03-05 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2019-03-05 Introduced in Senate IntroReferral 10000 9 Library of Congress B001310 Sen. Braun, Mike [R-IN] Mike Braun R IN N Health Drug safety, medical device, and laboratory regulation Manufacturing Marketing and advertising Medical research Prescription drugs Health 00 2019-03-05 Introduced in Senate 2021-08-04T15:50:40Z Accelerated Drug Approval for Prescription Therapies Act or the ADAPT Act

This bill authorizes the Food and Drug Administration (FDA)to create an expedited drug approval process specifically for drugs that are currently approved for sale in certain countries (i.e., a European Economic Area member country, Australia, Canada, Israel, Japan, New Zealand, South Africa, or Switzerland) and meet certain criteria. Such criteria shall include establishing that (1) the drug is safe and effective, (2) all relevant U.S. patents or legal exclusivities have expired, and (3) the United States has a public health or unmet medical need for the drug.

The FDA must process and review an application under this bill within 180 days of submission.

]]> ADAPT Act Display Title ADAPT Act Short Title(s) as Introduced ADAPT Act Introduced in Senate IS Short Title(s) as Introduced Accelerated Drug Approval for Prescription Therapies Act Introduced in Senate IS Official Title as Introduced A bill to provide for an accelerated approval pathway for certain drugs that are authorized to be lawfully marketed in other countries. Introduced in Senate IS 1588 116 SAMDT In the nature of a substitute. 2022-02-08T23:03:17Z 2020-05-19 Referred to the Committee on Health, Education, Labor, and Pensions. B001310 Sen. Braun, Mike [R-IN] Mike Braun R IN 2020-05-19T04:00:00Z Senate 116 S Senate S 658 ADAPT Act 2022-11-01T17:17:27Z 3 2020-05-19 0 Senate Referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2020-05-19 Senate amendment submitted Floor 91000 9 Library of Congress Introduced in Senate 2019-03-05T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-116s658is/xml/BILLS-116s658is.xml 2019-03-05 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.