3.0.0 1024 2023-01-11T19:47:52Z 2023-01-11T19:47:52Z Senate S S 2007-03-29 110 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2007-03-29T15:25:20Z 2007-03-29 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2007-03-29 Introduced in Senate IntroReferral 10000 9 Library of Congress G000445 Sen. Gregg, Judd [R-NH] Judd Gregg R NH N B001135 Sen. Burr, Richard [R-NC] Richard Burr R NC Mauze 2007-03-29 True C000560 Sen. Coburn, Tom [R-OK] TOM COBURN R OK 2007-03-29 True Health Clinical trials Commerce Consumer education Drug approvals Drug interactions Drug utilization Federal advisory bodies Government Operations and Politics Health information systems Health surveys Internet Medical ethics Medical records Medical statistics Pharmaceutical research Product safety Risk Science, Technology, Communications Standards Web sites Health 00 2007-03-29 Introduced in Senate 2007-07-03T19:57:56Z Safer Drug Assessment Technology Advancement Act or the Safer DATA Act - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to establish: (1) minimum standards for collection and transmission of postmarketing data elements from electronic health data systems; and (2) a validated and integrated postmarket risk identification and analysis system to integrate and analyze safety data from multiple sources.

Directs the Secretary to establish and maintain an active surveillance infrastructure to collect and report data for pharmaceutical postmarket risk identification and analysis.

Requires the Secretary to establish and implement procedures under which the Secretary may routinely collaborate with a qualified entity to: (1) clean, classify, or aggregate data collected and data that is publicly available or that is provided by the Secretary; (2) perform advanced research on identified drug safety risks; (3) identify safety questions that require further clinical study; and (4) convene an expert advisory committee to oversee the establishment of standards for the ethical and scientific uses for, and communication of, postmarketing data collected.

Requires the Secretary to improve the transparency of pharmaceutical data and allow patients and health care providers better access to pharmaceutical data by developing and maintaining an Internet site that: (1) provides comprehensive drug safety information for prescription drugs; and (2) improves communication of drug safety information to patients and providers.

]]> Safer Drug Assessment Technology Advancement Act Official Title as Introduced A bill to improve the underlying science of drug safety decisionmaking and strengthen the ability of the Food and Drug Administration to assess, manage, and communicate drug safety information to patients and providers. Introduced in Senate IS Display Title Safer Drug Assessment Technology Advancement Act Short Titles as Introduced Safer Drug Assessment Technology Advancement Act Short Titles as Introduced Safer DATA Act Introduced in Senate 2007-03-29T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-110s1024is/xml/BILLS-110s1024is.xml 2007-03-29 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.