Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations for 2003: Agricultural programsU.S. Government Printing Office, 2002 - United States |
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Page 11
... ensure the availability of medical products necessary for public health preparedness and for use against anthrax and other biological , chemical , or nuclear agents . We revisited how best to communicate with manufacturers to ensure the ...
... ensure the availability of medical products necessary for public health preparedness and for use against anthrax and other biological , chemical , or nuclear agents . We revisited how best to communicate with manufacturers to ensure the ...
Page 21
... ensure the accuracy , safety and effectiveness of the data gathered from these trials and submitted in product ... ensuring the protection of participants in FDA - regulated clinical research . We are committed to ensuring that the data ...
... ensure the accuracy , safety and effectiveness of the data gathered from these trials and submitted in product ... ensuring the protection of participants in FDA - regulated clinical research . We are committed to ensuring that the data ...
Page 39
... ensure sufficient availability of safe and effective medical products and a safe blood supply to support the development , maintenance ; and deployment of stockpiles of medical countermeasures , as well as support post - event follow ...
... ensure sufficient availability of safe and effective medical products and a safe blood supply to support the development , maintenance ; and deployment of stockpiles of medical countermeasures , as well as support post - event follow ...
Page 56
... ensure that an orange book listing is not frivolous or tenuous on its face . But it seems to me and FDA may ask for clarification to ensure that the patent covers the formula- tion of the proof product . That would require a fair amount ...
... ensure that an orange book listing is not frivolous or tenuous on its face . But it seems to me and FDA may ask for clarification to ensure that the patent covers the formula- tion of the proof product . That would require a fair amount ...
Page 68
... ensure that they are safe and they are effective for children . Essentially what the FDA is going to rely on is companies voluntarily conducting clinical trials on children . This has vast implications , in my view , for the health of ...
... ensure that they are safe and they are effective for children . Essentially what the FDA is going to rely on is companies voluntarily conducting clinical trials on children . This has vast implications , in my view , for the health of ...
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Common terms and phrases
90 percent act on 90 activities additional adverse events Agency Agency's Animal Drugs antimicrobial appropriate approved assessment associated bioterrorism blood Bonilla Bovine Spongiform Encephalopathy breast implant budget CFSAN clinical Committee compliance conduct consumers contamination costs Counter Terrorism CRAWFORD database dietary supplements disease domestic drug applications Drugs and Feeds electronic ensure establishments Estimate evaluate facilities Farm Credit Farm Credit System FDA's Federal fiscal Food and Drug food safety foodborne illness funding guidance HACCP Human Drugs implementation import increase industry inspections issues KAPTUR labeling laboratory Listeria monocytogenes loans mammography manufacturing medical devices medical products million monitoring MQSA Office pathogens patients PDUFA pediatric percent FY Performance Goals premarket proposed protect public health regulations regulatory request requirements Response Review and act risk Salmonella standards submissions surveillance System terrorist Undeclared color User Fees vaccines
Popular passages
Page 620 - October 31, 1977) provides that none of the funds appropriated or otherwise made available by this Act to the...
Page 438 - ... payment for publication of technical and Informational materials in professional and trade Journals...
Page 1193 - The four regulatory agencies that issued today's stateaents are the Office of the Comptroller of the Currency (OCC) , the Federal Deposit Insurance Corporation (FDIC), the Federal Reserve Board (FRB...
Page 1188 - Act of 1993 (GPRA) seeks to improve the effectiveness, efficiency, and accountability of federal programs by requiring federal agencies to set goals for program performance and to report on annual performance compared with the goals.
Page 21 - A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.
Page 388 - II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Page 326 - Available from National Technical Information Service, Springfield, VA 22151. ious requirements of the Environmental Protection Agency (EPA), the Nuclear Regulatory Commission (NRC), and other Federal and State agencies. The ultimate objective of these models is general prediction of the chemical concentrations to which organisms, including man, may be exposed following short or long-term releases of the chemical to the environment. Due to differences in intended uses, the models range in...
Page 306 - ... (A) officers and employees of the Food and Drug Administration, employees under contract with the Food and Drug Administration who work in facilities owned or leased for the Food and Drug Administration, advisory committees, and costs related to such officers, employees, and committees, (B) management of information, and the acquisition, maintenance, and repair of computer resources, (C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures,...
Page 260 - I would be happy to provide that information for the record. (The information follows...
Page 301 - Section 736 (g) (2) (B), states that fees: shall only be collected and available to defray increases in the costs of the resources allocated for the process for the review of human drug applications (including increases in such costs for an additional number of fulltime equivalent positions...