Code of Federal Regulations: Containing a Codification of Documents of General Applicability and Future Effect as of December 31, 1948, with Ancillaries and IndexU.S. General Services Administration, National Archives and Records Service, Office of the Federal Register, 2002 - Administrative law Special edition of the Federal Register, containing a codification of documents of general applicability and future effect ... with ancillaries. |
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Results 1-5 of 91
Page 20
( 2 ) An abbreviated new drug applica( 13 ) Metered - dose nedocromil sodium
tion conforming to $ 314 . 94 of this chaphuman drugs administered by oral in ter
is acceptable in lieu of a full new halation . drug application for any product in( 14
) ...
( 2 ) An abbreviated new drug applica( 13 ) Metered - dose nedocromil sodium
tion conforming to $ 314 . 94 of this chaphuman drugs administered by oral in ter
is acceptable in lieu of a full new halation . drug application for any product in( 14
) ...
Page 184
The Center may , on motion , sub - sequently amend its complaint to conform with
the evidence adduced during the administrative process , as justice may require .
( d ) The presiding officer will be assigned to the case upon the filing of the ...
The Center may , on motion , sub - sequently amend its complaint to conform with
the evidence adduced during the administrative process , as justice may require .
( d ) The presiding officer will be assigned to the case upon the filing of the ...
Page 251
The EIS will in all other respects conform to the requirements for EIS ' s as
specified in 40 CFR part 1502 and 1506 . 6 ( f ) . ( b ) Comments on the EIS may
be submitted after the approval of the drug , animal drug , biologic product , or
device .
The EIS will in all other respects conform to the requirements for EIS ' s as
specified in 40 CFR part 1502 and 1506 . 6 ( f ) . ( b ) Comments on the EIS may
be submitted after the approval of the drug , animal drug , biologic product , or
device .
Page 290
the risks and benefits of its use , poten - ( xviii ) Use of the investigational drug tial
side effects , and other pertinent in - without informed consent otherwise
formation about the appropriate use of conforms with applicable law . the product
.
the risks and benefits of its use , poten - ( xviii ) Use of the investigational drug tial
side effects , and other pertinent in - without informed consent otherwise
formation about the appropriate use of conforms with applicable law . the product
.
Page 296
This section and conforming regulations require an applicant whose submission
relies in part on clinical data to disclose certain financial arrangements between
sponsor ( s ) of the covered studies and the clinical investigators and certain ...
This section and conforming regulations require an applicant whose submission
relies in part on clinical data to disclose certain financial arrangements between
sponsor ( s ) of the covered studies and the clinical investigators and certain ...
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Common terms and phrases
accordance action advisory committee agency amended amounts animal application approval authority batches Biologics Branch CDRH Center certification chapter color additive Commissioner Compliance conduct conform considered contain copy cosmetics decision Deputy Direc Deputy Director designated determination device Director and Deputy disclosure Division Dockets documents Drug Administration effective electronic employee established Evaluation exempt Federal filed final Food and Drug functions further hearing human identity individual initial intended interest involved issue Labeling listed Management manufacturing matter means meeting ment mixtures notice Operations paragraph participant party percent person petition Policy practice prepared present presiding officer procedures proceeding proposed reasonable recall records regulations regulatory relating reports request requirements Research responsible restrictions safely Science Services specifications standards statement submission submitted Subpart tion tors unless views written
Popular passages
Page 300 - 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 329 - 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 191 - 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 467 - Department of Agriculture (Parts 2900—2999) XXX Office of the Chief Financial Officer, Department of Agriculture (Parts 3000—3099) XXXI Office of Environmental Quality, Department of Agriculture (Parts 3100—3199) XXXII Office of Procurement and Property Management, Department of Agriculture (Parts 3200—3299) Chap.
Page 210 - ... 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...
Page 412 - 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 240 - ... 9 ) to either House of Congress, or, to the extent of matter within its jurisdiction, any committee or subcommittee thereof, any joint committee of Congress or subcommittee of any such joint committee...
Page 195 - Never use any information coming to him confidentially in the performance of governmental duties as a means for making private profit. 9. Expose corruption wherever discovered. 10. Uphold these principles, ever conscious that public office is a public trust.
Page 304 - Except when an expedited review procedure is used (see §56.110), review proposed research at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. In order for the research to be approved, it shall receive the approval of a majority of those members present at the meeting.
Page 5 - Labeling includes all written, printed, or graphic matter accompanying an article at any time while such article is in interstate commerce or held for sale after shipment or delivery in interstate commerce. (b) "Label" means any display of written, printed, or graphic matter on the immediate container of any article, or any such matter affixed to any consumer commodity or affixed to or appearing upon a package containing any consumer commodity.
Bibliographic information
| Title | Code of Federal Regulations: Containing a Codification of Documents of General Applicability and Future Effect as of December 31, 1948, with Ancillaries and Index |
| Contributor | United States. Office of the Federal Register |
| Publisher | U.S. General Services Administration, National Archives and Records Service, Office of the Federal Register, 2002 |
| Original from | the University of Michigan |
| Digitized | 15 Aug 2007 |
| Export Citation | BiBTeX EndNote RefMan |