U.S. Congress - S.882 Drug and Device Accountability Act of 2009
S.882 - Drug and Device Accountability Act of 2009
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. view all titles (2)
All Bill Titles
- Official: 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. as introduced.
- Short: Drug and Device Accountability Act of 2009 as introduced.
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Official Summary
4/23/2009--Introduced.Drug and Device Accountability Act of 2009 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to revise provisions regarding the registration of drug and device establishments, including to: (1) expand the information required to be included in a registration;Official Summary
4/23/2009--Introduced.Drug and Device Accountability Act of 2009 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to revise provisions regarding the registration of drug and device establishments, including to:(1) expand the information required to be included in a registration; and
(2) provide for risk-based inspections. Includes in the definition of "drug" a precursor ingredient. Requires the Secretary of Health and Human Services (HHS) to assess the registration exemption for manufacturers of harmless inactive ingredients that become components of drugs. 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. Deems a drug or device to be misbranded unless certain conditions related to labeling for country of manufacture and provision of required information on importation are met. Sets forth provisions governing importation of a drug and its components. 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 and personal knowledge of information submitted. Establishes whistleblower protection for employees providing information regarding a drug, biological product, or device. Requires the Secretary to contract with the Institute of Medicine to evaluate:
(1) the organizational structure and operations of the Food and Drug Administration (FDA) with respect to the review of medical devices for clearance and for premarket approval under FFDCA; and
(2) the analytical and methodological tools used to conduct such reviews. Directs the Secretary to establish a corps of inspectors dedicated to inspections of foreign establishments and facilities. Sets forth enforcement provisions.
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Recent Blog Coverage
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Pater Lorson Monographien | Peter Burg Werke
C. Mertens, S. J., in: NRTh Jg. 85, 1953, S. 882. Beitrag geschrieben von admin am Montag 20. Dezember 2010 um 23:45 und abgelegt unter Pater Lorson. Kommentare zu diesen Eintrag im RSS 2.0 Feed. Kommentare sind derzeit geschlossen, ...
Rhode Island's Future - Tax Pollution Not People
There was also Senate Bill S.882, "Energy and Climate Policy Act of 1999." This bill amends the Energy Policy Act of 1992 (EPAct) to: • develop a program of public recognition for those entities that have achieved certified greenhouse ...
Der Blog der Rechtsanwaltskanzlei Kotz
BGH FamRZ 2007, S. 793 f; BGH FamRZ 2007, S. 882 f; BGH FamRZ 2007, 1303). Ob im laufenden Jahr von der Möglichkeit der Eintragung eines Freibetrages Gebrauch zu machen ist, richtet sich nach den Umständen des Einzelfalls. ...
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