3.0.0 3409 2020-02-10T17:02:03Z 2020-02-10T17:02:03Z Senate S S 2008-07-31 110 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2008-08-01T02:05:21Z 2008-07-31 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2008-07-31 Introduced in Senate IntroReferral 10000 9 Library of Congress K000105 Sen. Kennedy, Edward M. [D-MA] EDWARD KENNEDY D MA MOORE N G000386 Sen. Grassley, Chuck [R-IA] Charles Grassley R IA E. 2008-07-31 True Health Administrative fees Clinical trials Commerce Communication in medicine Damages Data banks Defective products Drug adulteration Drug approvals Drug industry Drugs Economics and Public Finance Fines (Penalties) Foreign Trade and International Finance Government Operations and Politics Government paperwork Governmental investigations Health information systems Imports Internet Labeling Law Licenses Medical technology Product safety Science, Technology, Communications Subpoena Wage restitution Whistle blowing Health 00 2008-07-31 Introduced in Senate 2008-12-12T22:27:32Z Drug and Device Accountability Act of 2008 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to deem a drug or device to be misbranded unless certain conditions related to registration of establishments, identification of prior transactions, labeling for country of manufacture, and provision of required information on importation are met.

Includes in the definition of "drug" a precursor ingredient.

Repeals the registration exemption for manufacturers of harmless inactive ingredients that become components of drugs.

Expands the information required to be included for registration of establishments.

Deems a drug to be adulterated if certain conditions related to verification of identity and purity, identification of establishments, consistency with current manufacturing technologies, and conformity with good distribution and import practices are not met.

Sets forth provisions governing importation of a drug.

Sets forth required actions, including cessation of distribution, if there is a reasonable probability that a drug intended for human use would cause serious, adverse health consequences or death.

Establishes actions manufacturers must take regarding any defective drug.

Sets forth additional required certifications for submissions related to drugs and devices regarding accuracy of information submitted and personal knowledge of such information.

Establishes whistleblower protection for employees providing information regarding a drug, biological product, or device.

Directs the Secretary of Health and Human Services to establish and maintain a corps of inspectors dedicated to inspections of foreign establishments and foreign facilities.

Authorizes the Secretary to conduct investigations, subpoena witnesses, and compel attendance of witnesses as necessary to carry out authority under the FFDCA or provisions governing the regulation of biological products.

Requires reports to the Secretary regarding certain civil actions involving a regulated product.

]]> Drug and Device Accountability Act of 2008 Short Titles as Introduced Drug and Device Accountability Act of 2008 Display Title Drug and Device Accountability Act of 2008 Official Title as Introduced A bill to amend the Federal Food, Drug, and Cosmetic Act to ensure the safety and quality of medical products and enhance the authorities of the Food and Drug Administration, and for other purposes. Introduced in Senate 2008-07-31T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-110s3409is/xml/BILLS-110s3409is.xml 2008-07-31 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.