3.0.0 3432 2022-02-09T03:26:26Z 2022-02-09T08:27:48Z Senate S 2020-03-10 116 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2020-03-10T22:02:48Z Securing America’s Medicine Cabinet Act of 2020 116 6708 HR 2020-05-05 Referred to the House Committee on Energy and Commerce. Identical bill CRS 2020-03-10 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2020-03-10 Introduced in Senate IntroReferral 10000 9 Library of Congress B001243 Sen. Blackburn, Marsha [R-TN] Marsha Blackburn R TN N M000639 Sen. Menendez, Robert [D-NJ] Robert Menendez D NJ 2020-03-10 True M001197 Sen. McSally, Martha [R-AZ] Martha McSally R AZ 2020-03-12 False C001095 Sen. Cotton, Tom [R-AR] Tom Cotton R AR 2020-03-19 False S001184 Sen. Scott, Tim [R-SC] Tim Scott R SC 2020-06-04 False L000594 Sen. Loeffler, Kelly [R-GA] Kelly Loeffler R GA 2020-06-11 False Health Advanced technology and technological innovations Congressional oversight Drug safety, medical device, and laboratory regulation Educational facilities and institutions Emergency medical services and trauma care Government information and archives Health technology, devices, supplies Higher education Manufacturing Medical research Prescription drugs Research and development Technology assessment Health 00 2020-03-10 Introduced in Senate 2021-01-27T16:12:18Z Securing America's Medicine Cabinet Act of 2020

This bill encourages the development and approval of advanced pharmaceutical manufacturing technologies and designates certain university research centers to assist in developing such technologies.

The Food and Drug Administration (FDA) must continue to evaluate and approve new drug manufacturing technologies included in an application for drug approval and expedite the development and implementation of such technologies. The FDA must designate such a technology as an advanced manufacturing technology if it is likely to (1) prevent or resolve a drug shortage, (2) maintain an adequate supply of critical medications for national emergencies, or (3) promote the adoption of innovative approaches to drug design and manufacturing.

The sponsor of such a designated technology must provide the FDA with certain related scientific evidence. After receiving this evidence, if the FDA validates the technology for a proposed use, then the sponsor may use the validated technology across multiple manufacturing product lines within the same use context without obtaining additional FDA validation.

The FDA must designate certain institutions of higher education as National Centers of Excellence in Advanced Pharmaceutical Manufacturing. Among other requirements, such centers must demonstrate the ability to provide federal agencies with technical assistance and to train a future workforce in such technologies.

]]> Securing America’s Medicine Cabinet Act of 2020 Display Title Securing America’s Medicine Cabinet Act of 2020 Short Title(s) as Introduced Securing America’s Medicine Cabinet Act of 2020 Introduced in Senate IS Official Title as Introduced A bill to support the advanced manufacturing technologies program of the Food and Drug Administration, to establish National Centers of Excellence in Advanced Pharmaceutical Manufacturing, and for other purposes. Introduced in Senate IS Introduced in Senate 2020-03-10T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-116s3432is/xml/BILLS-116s3432is.xml 2020-03-10 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.