Code of Federal Regulations: Containing a Codification of Documents of General Applicability and Future Effect as of December 31, 1948, with Ancillaries and IndexDivision of the Federal Register, the National Archives, 1999 Special edition of the Federal Register, containing a codification of documents of general applicability and future effect ... with ancillaries. |
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1.5. rezultāts no 37.
5. lappuse
... hearing to iden- tical , related , and similar drug products . Subpart B - Specific Administrative Rulings and Decisions 310.100 New drug status opinions ; statement of policy . 310.103 New drug substances intended for hypersensitivity ...
... hearing to iden- tical , related , and similar drug products . Subpart B - Specific Administrative Rulings and Decisions 310.100 New drug status opinions ; statement of policy . 310.103 New drug substances intended for hypersensitivity ...
8. lappuse
... hearing to identical , related , and similar drug products . ( a ) The Food and Drug Administra- tion's conclusions on the effectiveness of drugs are currently being published in the FEDERAL REGISTER as Drug Effi- cacy Study ...
... hearing to identical , related , and similar drug products . ( a ) The Food and Drug Administra- tion's conclusions on the effectiveness of drugs are currently being published in the FEDERAL REGISTER as Drug Effi- cacy Study ...
79. lappuse
... hearing before FDA under part 16 on the question of whether the IND should be terminated . The sponsor's re- quest for a regulatory hearing must be made within 10 days of the sponsor's receipt of FDA's notification of non- acceptance ...
... hearing before FDA under part 16 on the question of whether the IND should be terminated . The sponsor's re- quest for a regulatory hearing must be made within 10 days of the sponsor's receipt of FDA's notification of non- acceptance ...
80. lappuse
... hearing under part 16 on the question of wheth- er the IND should be reinstated . ( Collection of information requirements ap- proved by the Office of Management and Budget under control number 0910-0014 ) [ 52 FR 8831 , Mar. 19 , 1987 ...
... hearing under part 16 on the question of wheth- er the IND should be reinstated . ( Collection of information requirements ap- proved by the Office of Management and Budget under control number 0910-0014 ) [ 52 FR 8831 , Mar. 19 , 1987 ...
88. lappuse
... hearing under part 16 on the question of whether the investigator is entitled to receive in- vestigational new drugs . ( b ) After evaluating all available in- formation , including any explanation presented by the investigator , if the ...
... hearing under part 16 on the question of whether the investigator is entitled to receive in- vestigational new drugs . ( b ) After evaluating all available in- formation , including any explanation presented by the investigator , if the ...
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Bieži izmantoti vārdi un frāzes
abbre abbreviated application abbreviated new drug acid active ingredient added adverse drug experience agency amended application or abbreviated aspirin Authority citation revised bacitracin bioavailability bioequivalence cation Center for Drug certification chapter clinical investigation consult a doctor Department digoxin dosage form dose Drug Administration drug application Drug Evaluation drug prod drug product Drug products containing ephedrine Evaluation and Research Federal Acquisition Regulation Federal Food FEDERAL REGISTER Food and Drug grams graph gredients hearing introductory text investigational new drug labeling marketing ment milligrams milligrams in 24 misbranded neomycin Office oral dosage orphan drug OTC drug product over-the-counter paragraph patent percent physician plication polymyxin proposed protocol recognized as safe Redesignated reference listed drug regulations removing request safe and effective safety salicylate Salicylic acid Sodium sponsor submission sulfate taining tion tive treatment unless directed viated warning
Populāri fragmenti
158. lappuse - ... drug, based on a fair evaluation of all material facts, is false or misleading in any particular and was not corrected within a reasonable time after receipt of written notice from the Secretary specifying the matter complained of. Any order under this subsection shall state the findings upon which it is based.
314. lappuse - Board of Governors of the Federal Reserve System (Part 6801) LIX National Aeronautics and Space Administration (Part 6901) LX United States Postal Service (Part 7001) LXI National Labor Relations Board (Part 7101...
172. lappuse - Act if it (1) accords to the specifications of the foreign purchaser, (2) is not in conflict with the laws of the country to which it is intended for export, and (3) is labeled on the outside of the shipping package to show that it is intended for export.
332. lappuse - Civil Rights, Commission on Civil Rights, Office for Coast Guard Coast Guard (Great Lakes Pilotage) Commerce Department Census Bureau Economic Affairs, Under Secretary Economic Analysis, Bureau of Economic Development Administration Emergency Management and Assistance...
171. lappuse - As used in this subsection and subsection (e), the term "substantial evidence" means evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly be, concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended,...
230. lappuse - For purposes of this section and of section 502(1), the term "antibiotic drug" means any drug intended for use by man containing any quantity of any chemical substance which is produced by a micro-organism and which has the capacity to inhibit or destroy micro-organisms in dilute solution (including the chemically synthesized equivalent of any such substance).
316. lappuse - Cooperative State Research, Education, and Extension Service, Department of Agriculture (Parts 34003499) XXXV Rural Housing Service, Department of Agriculture (Parts 3500 3599) XXXVI National Agricultural Statistics Service, Department of Agriculture (Parts 36003699...
320. lappuse - Office of the Assistant Secretary for Housing Federal Housing Commissioner, Department of Housing and Urban Development (Section 8 Housing Assistance Programs, Section 202 Direct Loan Program, Section 202 Supportive Housing for the Elderly Program and Section 811 Supportive Housing for Persons With Disabilities Program) (Parts...
307. lappuse - If offered for use in arthritis or rheumatism, in juxtaposition therewith, the statement: Caution If pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age, consult a physician immediately.
331. lappuse - Agency Architectural and Transportation Barriers Compliance Board Arctic Research Commission Armed Forces Retirement Home Army Department Engineers, Corps of Federal Acquisition Regulation Benefits Review Board Bilingual Education and Minority Languages Affairs, Office of Blind or Severely Disabled, Committee for Purchase From People Who Are Broadcasting Board of Governors Federal Acquisition Regulation Census Bureau Centers for Medicare...