The Code of Federal Regulations of the United States of AmericaU.S. Government Printing Office, 1997 - 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 14
... application . If such ap- plication is not submitted at or prior to the hearing , the district director shall specify a time limit , reasonable in the light of the circumstances , for filing such application . §1.95 Application for ...
... application . If such ap- plication is not submitted at or prior to the hearing , the district director shall specify a time limit , reasonable in the light of the circumstances , for filing such application . §1.95 Application for ...
Page 15
... application for authorization with the district director . ( d ) If ownership of an article covered by an authorization changes before the operations specified in the authoriza- tion have been completed , the original owner will be held ...
... application for authorization with the district director . ( d ) If ownership of an article covered by an authorization changes before the operations specified in the authoriza- tion have been completed , the original owner will be held ...
Page 20
... application , a new animal drug applica- tion , or in the case of a certifiable anti- biotic an antibiotic application for the drug product has been approved , a peti- tion has been filed as provided by para- graph ( f ) of this section ...
... application , a new animal drug applica- tion , or in the case of a certifiable anti- biotic an antibiotic application for the drug product has been approved , a peti- tion has been filed as provided by para- graph ( f ) of this section ...
Page 21
... application is waived . ( h ) ( 1 ) Each manufacturer of a drug product listed in paragraph ( e ) of this section that is not covered by an ap- proved new drug application shall sub- mit a new drug application in accord with §314.50 of ...
... application is waived . ( h ) ( 1 ) Each manufacturer of a drug product listed in paragraph ( e ) of this section that is not covered by an ap- proved new drug application shall sub- mit a new drug application in accord with §314.50 of ...
Page 23
... application , investigational device exemption ( IDE ) , new drug ap- plication ( NDA ) , antibiotic application , biological product or establishment li- cense application , device premarket notification , device reclassification pe ...
... application , investigational device exemption ( IDE ) , new drug ap- plication ( NDA ) , antibiotic application , biological product or establishment li- cense application , device premarket notification , device reclassification pe ...
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Common terms and phrases
acid action administrative record advisory committee agency amended amounts consistent animal drug approval biological cation CBER CDER CDRH CFSAN chapter color additive D&C Color additive mixtures coloring purposes Commissioner of Food conform in identity contain Cosmetic Act D&C Orange D&C Red D&C Yellow Deputy Center Deputy Direc Deputy Director diluents Director and Deputy Dockets Management Branch Drug Administration drug applications employee environmental Exemption from certification externally applied drugs FD&C Federal Acquisition Regulation Federal Food FEDERAL REGISTER filed food additive Food and Drug hearing identity and specifications issue Lead as Pb lic health listed manufacturing practice matter ment metic mixtures for coloring mixtures prepared therefrom naphthalenedisulfonic notice paragraph participation percent person petition presiding officer procedures public disclosure quirements regulations regulatory request restrictions safely salt sory submitted Subpart tification tion tive Total color
Popular passages
Page 255 - 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 185 - Although relevant, evidence may be excluded if its probative value is substantially outweighed by the danger of unfair prejudice, confusion of the issues, or misleading the jury, or by considerations of undue delay, waste of time, or needless presentation of cumulative evidence.
Page 188 - 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 268 - IRB shall include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas. d Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution. e...
Page 261 - ... participation, a description of the procedures to be followed, and identification of any procedures which are experimental; (2) A description of any reasonably foreseeable risks or discomforts to the subject; (3) A description of any benefits to the subject or to others which may reasonably be expected from the research; (4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject; (5) A statement describing the extent, if any,...
Page 260 - ... rights, and whom to contact in the event of a research-related injury to the subject; and (8) A statement that participation is voluntary, refusal to participate will Involve no penalty or loss of benefits to which the subject is otherwise entitled...
Page 374 - 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 84 - advisory committee" means any committee, board, commission, council, conference, panel, task force, or other similar group, or any subcommittee or other subgroup thereof...
Page 374 - HALDOL tablets contain FD&C Yellow No 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals, especially in those who have...
Page 204 - ... would disclose techniques and procedures for law enforcement investigations or prosecutions, or would disclose guidelines for law enforcement investigations or prosecutions if such disclosure could reasonably be expected to risk circumvention of the law...