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 vi
... approve an incorporation by reference only when the requirements of 1 CFR part 51 are met . Some of the elements on which approval is based are : ( a ) The incorporation will substantially reduce the volume of material pub- lished in ...
... approve an incorporation by reference only when the requirements of 1 CFR part 51 are met . Some of the elements on which approval is based are : ( a ) The incorporation will substantially reduce the volume of material pub- lished in ...
Page 21
... approval of an ap- plication or terminate an IND or INAD notice in accordance with the applica- ble provisions of section 505 of the act and parts 312 and 314 of this chapter , or 21 Food and Drug Administration , HHS §2.125.
... approval of an ap- plication or terminate an IND or INAD notice in accordance with the applica- ble provisions of section 505 of the act and parts 312 and 314 of this chapter , or 21 Food and Drug Administration , HHS §2.125.
Page 22
... approvals from more than one FDA component for such combina- tion products . The second purpose of this regulation is to enhance the effi- ciency of agency management and op- erations by providing procedures for determining which agency ...
... approvals from more than one FDA component for such combina- tion products . The second purpose of this regulation is to enhance the effi- ciency of agency management and op- erations by providing procedures for determining which agency ...
Page 24
... approval or a required investigational notice . Sponsors are encouraged to file a request for designation as soon as there is sufficient information for the agency to make a determination . ( c ) What to file : an original and two ...
... approval or a required investigational notice . Sponsors are encouraged to file a request for designation as soon as there is sufficient information for the agency to make a determination . ( c ) What to file : an original and two ...
Page 25
... approval , is mar- keted as not being subject to pre- market approval , or has received an in- vestigational exemption , the identity of the sponsors , and the status of any discussions or agreements between the sponsors regarding the ...
... approval , is mar- keted as not being subject to pre- market approval , or has received an in- vestigational exemption , the identity of the sponsors , and the status of any discussions or agreements between the sponsors regarding the ...
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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...