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 23
... proposed a new prescription drug labeling rule . The proposed new labeling will reduce practitioners ' time spent looking for information , decrease the number of preventable medical errors , and improve treatment effectiveness . An ...
... proposed a new prescription drug labeling rule . The proposed new labeling will reduce practitioners ' time spent looking for information , decrease the number of preventable medical errors , and improve treatment effectiveness . An ...
Page 115
... proposed a rule about a year ago . I am wondering what is the status of the rule . Has it been sent to OMB ? Will we see enforce- ment of it ? Can you bring us up to date on where that is ? Dr. CRAWFORD . It came out before I did , so I ...
... proposed a rule about a year ago . I am wondering what is the status of the rule . Has it been sent to OMB ? Will we see enforce- ment of it ? Can you bring us up to date on where that is ? Dr. CRAWFORD . It came out before I did , so I ...
Page 142
... proposed to withdraw approvals of the new animal drug applications for use of fluoroquinolone antimicrobial drugs in poultry . One of the two sponsors , Abbott has voluntarily withdrawn the product . Bayer has requested a hearing . If ...
... proposed to withdraw approvals of the new animal drug applications for use of fluoroquinolone antimicrobial drugs in poultry . One of the two sponsors , Abbott has voluntarily withdrawn the product . Bayer has requested a hearing . If ...
Page 158
... Proposed Retromont Grand Totale POUFA w / Accruale Accruale 261 10 3.119 235 4,776 ( 1 ) 392 2 247 $ 7,498 $ 17.919 247 $ 25,417 ( 300 ) 13 2819 6,333 13 8.152 234 4.670 12,686 234 17,265 User Fees Human Droge CDER ( BA ) Field ...
... Proposed Retromont Grand Totale POUFA w / Accruale Accruale 261 10 3.119 235 4,776 ( 1 ) 392 2 247 $ 7,498 $ 17.919 247 $ 25,417 ( 300 ) 13 2819 6,333 13 8.152 234 4.670 12,686 234 17,265 User Fees Human Droge CDER ( BA ) Field ...
Page 165
... proposed rule on dietary supplement good manufacturing practices ? If not , why , and when will it be published ? Response : The proposed Current Good Manufacturing Practices , CGMPs , for dietary supplements rule that is currently ...
... proposed rule on dietary supplement good manufacturing practices ? If not , why , and when will it be published ? Response : The proposed Current Good Manufacturing Practices , CGMPs , for dietary supplements rule that is currently ...
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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
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...