The Code of Federal Regulations of the United States of AmericaU.S. Government Printing Office, 1993 - Administrative law The Code of Federal Regulations is the codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government. |
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Page 23
... Evaluation and Research , the Center for Devices and Radiological Health , or the Center for Drug Evaluation and Research . ( c ) Applicant means any person who submits or plans to submit an applica- tion to the Food and Drug Administra ...
... Evaluation and Research , the Center for Devices and Radiological Health , or the Center for Drug Evaluation and Research . ( c ) Applicant means any person who submits or plans to submit an applica- tion to the Food and Drug Administra ...
Page 24
... Evaluation and Research have entered into agree- ments clarifying product jurisdictional issues . These guidance ... Evaluation and Research and the Center for Devices and Radiological Health ; " " Intercenter Agreement Be- tween the ...
... Evaluation and Research have entered into agree- ments clarifying product jurisdictional issues . These guidance ... Evaluation and Research and the Center for Devices and Radiological Health ; " " Intercenter Agreement Be- tween the ...
Page 29
... evaluation of specific drugs and de- vices regulated by FDA which are in- tended to result in recommendations for regulatory decisions under the Federal Food , Drug , and Cosmetic Act and which are concerned with matters listed in 5 ...
... evaluation of specific drugs and de- vices regulated by FDA which are in- tended to result in recommendations for regulatory decisions under the Federal Food , Drug , and Cosmetic Act and which are concerned with matters listed in 5 ...
Page 35
... Evaluation and Research ( CBER ) . ( ii ) The Director , Office of Manage- ment , CBER . ( iii ) The Directors and Deputy Di- rectors of the Offices of Compliance , Biological Product Review and Biolog- ics Research , CBER . ( iv ) The ...
... Evaluation and Research ( CBER ) . ( ii ) The Director , Office of Manage- ment , CBER . ( iii ) The Directors and Deputy Di- rectors of the Offices of Compliance , Biological Product Review and Biolog- ics Research , CBER . ( iv ) The ...
Page 36
... Evaluation and Research ( CDER ) . ( ii ) The Directors and Deputy Direc- tors of the Offices of Management , Epidemiology and Biostatistics , Com- pliance , Drug Evaluation I , Drug Eval- uation II , Drug Standards , and Re- search ...
... Evaluation and Research ( CDER ) . ( ii ) The Directors and Deputy Direc- tors of the Offices of Management , Epidemiology and Biostatistics , Com- pliance , Drug Evaluation I , Drug Eval- uation II , Drug Standards , and Re- search ...
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Common terms and phrases
acid action additive shall conform administrative record advisory committee agency amended amounts consistent animal drug approval Authority citation batches thereof cations CBER CDER CDRH Center certifica chapter color additive D&C Color additive mixtures coloring foods coloring purposes Commissioner of Food conform in identity contain Cosmetic Act D&C Orange D&C Red D&C Yellow Deputy Direc diluents Director and Deputy Dockets Management Branch Drug Administration drug application Drug Evaluation employee environmental Exemption from certification externally applied drugs FD&C Federal Food FEDERAL REGISTER filed food additive Food and Drug hearing Identity and specifications issue Lead as Pb listed manufacturing practice matter ment metic million mixtures for coloring mixtures prepared therefrom notice paragraph participant person petition presiding officer procedures proposed public disclosure regulations regulatory request requirements of section restrictions revised safely standards of identity submitted Subpart thereof are exempt tive Total color
Popular passages
Page 186 - A trade secret may consist of any formula, pattern, device or compilation of information which is used in one's business, and which gives him an opportunity to obtain an advantage over competitors who do not know or use it.
Page 172 - Never discriminate unfairly by the dispensing of special favors or privileges to anyone, whether for remuneration or not; and never accept for himself or his family, favors or benefits under circumstances which might be construed by reasonable persons as influencing the performance of his governmental duties.
Page 6 - label" means a display of written, printed, or graphic matter upon the immediate container of any article ; and a requirement made by or under authority of this Act that any word, statement, or other information appear on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper. (1) The...
Page 271 - ... color additive" means a material which — (A) is a dye, pigment, or other substance made by a process of synthesis or similar artifice, or extracted, isolated, or otherwise derived, with or without intermediate or final change of identity, from a vegetable, animal, mineral, or other source, and...
Page 246 - IRB membership. (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members...
Page 351 - USP) 2.5. 5, and 10 mg contain FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen In patients who also have aspirin hypersensitivity.
Page 172 - Any person in Government service should: 1. Put loyalty to the highest moral principles and to country above loyalty to persons, party, or Government department. 2. Uphold the Constitution, laws, and legal regulations of the United States and of all governments therein and never be a party to their evasion.
Page 236 - food additive" means any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food...
Page 80 - advisory committee" means any committee, board, commission, council, conference, panel, task force, or other similar group, or any subcommittee or other subgroup thereof...
Page 215 - September 27, 1975. (h) Rights of Legal Guardians. For the purposes of this section, the parent of any minor, or the legal guardian of any individual who has been declared to be incompetent due to physical or mental incapacity or age by a court of competent jurisdiction, may act on behalf of the individual.