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 26
... approvals ( PMAs ) , of which 24 were for devices with novel technologies or new uses . The median total approval time for the 54 products was 11.3 months . These major product approvals are expected to benefit a large number of ...
... approvals ( PMAs ) , of which 24 were for devices with novel technologies or new uses . The median total approval time for the 54 products was 11.3 months . These major product approvals are expected to benefit a large number of ...
Page 43
... approval times of standard new drug and biologics applications . Preliminary data indicates that approval times have begun to increase because more applications require multiple review cycles to reach approval . The Agency is watching ...
... approval times of standard new drug and biologics applications . Preliminary data indicates that approval times have begun to increase because more applications require multiple review cycles to reach approval . The Agency is watching ...
Page 58
... approvals , et cetera , the desperate need that we have for trying to get cost sav- ings from prescription drugs through timely approval of generic drugs , as we look at your budget submission , you are asking for what you call an ...
... approvals , et cetera , the desperate need that we have for trying to get cost sav- ings from prescription drugs through timely approval of generic drugs , as we look at your budget submission , you are asking for what you call an ...
Page 68
... approve that drug . The generic is not willing to go out on the market , even though it has FDA approval , because of the risks of the patent determination . So , to ask us to be making those determinations would be a very , very ...
... approve that drug . The generic is not willing to go out on the market , even though it has FDA approval , because of the risks of the patent determination . So , to ask us to be making those determinations would be a very , very ...
Page 72
... approval , at least on a temporary basis , to every drug , therapeutic , vaccine , anti - toxin that is to be administered to humans and every diagnostic tool that is to be used clinically must be reviewed and approved by FDA . Since ...
... approval , at least on a temporary basis , to every drug , therapeutic , vaccine , anti - toxin that is to be administered to humans and every diagnostic tool that is to be used clinically must be reviewed and approved by FDA . Since ...
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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
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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...