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, 2001 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 48.
22. lappuse
... protocol shall contain all of the essential elements set forth in paragraph ( d ) of this sec- tion . The tests shall not be initiated prior to receiving notification from the Food and Drug Administration that the bioavailability protocol ...
... protocol shall contain all of the essential elements set forth in paragraph ( d ) of this sec- tion . The tests shall not be initiated prior to receiving notification from the Food and Drug Administration that the bioavailability protocol ...
23. lappuse
... protocol and / or the results of the in vivo bioavailability tests showing ade- quate evidence of the product's bio- availability within the times specified in paragraph ( a ) ( 1 ) ( vii ) of this section and / or to comply with all of ...
... protocol and / or the results of the in vivo bioavailability tests showing ade- quate evidence of the product's bio- availability within the times specified in paragraph ( a ) ( 1 ) ( vii ) of this section and / or to comply with all of ...
57. lappuse
... Protocol amendments . Information amendments . IND safety reports . 312.33 Annual reports . 312.34 Treatment use of an investigational new drug . 312.35 Submissions for treatment use . 312.36 Emergency use of 57 Food and Drug ...
... Protocol amendments . Information amendments . IND safety reports . 312.33 Annual reports . 312.34 Treatment use of an investigational new drug . 312.35 Submissions for treatment use . 312.36 Emergency use of 57 Food and Drug ...
58. lappuse
... protocols . 312.84 Risk - benefit analysis in review of marketing applications for drugs to treat life - threatening and severely - debilitating illnesses . 312.85 312.86 Phase 4 studies . Focused FDA regulatory research . 312.87 Active ...
... protocols . 312.84 Risk - benefit analysis in review of marketing applications for drugs to treat life - threatening and severely - debilitating illnesses . 312.85 312.86 Phase 4 studies . Focused FDA regulatory research . 312.87 Active ...
59. lappuse
... protocol , selection or monitoring of investigations , evalua- tion of reports , and preparation of ma- terials to be submitted to the Food and Drug Administration . FDA means the Food and Drug Ad- ministration . IND means an ...
... protocol , selection or monitoring of investigations , evalua- tion of reports , and preparation of ma- terials to be submitted to the Food and Drug Administration . FDA means the Food and Drug Ad- ministration . IND means an ...
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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 chapter clinical investigation consult a doctor contains the following Department dient digoxin dosage form dose Drug Administration drug application drug prod drug product Drug products containing effective date ephedrine Federal Acquisition Regulation Federal Food FEDERAL REGISTER Food and Drug grams gredients homosalate ingre introductory text investigational new drug labeling marketing ment milligrams milligrams in 24 misbranded neomycin Office OMB number oral dosage orphan drug OTC drug product over-the-counter paragraph patent percent plication polymyxin protocol recognized as safe Redesignated reference listed drug regulations request safe and effective safety salicylate Sodium sponsor submission submitted sulfate sunscreen taining tion tive treatment unless directed warning
Populāri fragmenti
10. lappuse - Commissioner finds such requirements are not necessary for the protection of the public health by reason of the drug's toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, and he finds that the drug is safe and effective for use in self-medication as directed in proposed labeling.
337. lappuse - Advisory Council on Historic Preservation African Development Foundation Federal Acquisition Regulation Agency for International Development, United States Federal Acquisition Regulation Agricultural Marketing Service Agricultural Research Service Agriculture Department Agricultural Marketing Service Agricultural Research Service Animal and Plant Health Inspection Service Chief Financial Officer, Office of Commodity Credit Corporation Cooperative State Research, Education, and Extension Service Economic...
154. 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.
147. lappuse - ... 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, or suggested in the labeling or proposed labeling thereof.
321. lappuse - XXVI Office of Inspector General, Department of Agriculture (Parts 2600—2699) XXVII Office of Information Resources Management, Department of Agriculture (Parts 2700—2799) XXVIII Office of Operations, Department of Agriculture (Parts 2800— 2899) XXIX Office of Energy, 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...
90. lappuse - Non-Therapeutic Biomedical Research Involving Human Subjects (Non-Clinical Biomedical Research) 1. In the purely scientific application of medical research carried out on a human being, it is the duty of the physician to remain the protector of the life and health of that person on whom biomedical research is being carried out. 2. The subjects should be volunteers — either healthy persons or patients for whom the experimental design is not related to the patient's illness. 3. The investigator or...
84. lappuse - The investigator is required to furnish his reports to the sponsor of the drug who is responsible for collecting and evaluating the results obtained by various investigators. The sponsor is required to present progress reports to the Food and Drug Administration at appropriate intervals not exceeding 1 year.
90. lappuse - Informed of the alms, methods, anticipated benefits and potential hazards of the study and the discomfort It may entail. He or she should be informed that he or she Is at liberty to abstain from participation in the study and that he or she is free to withdraw his or her consent to participation at any time.
254. lappuse - Act. (b) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted. [45 FR 36390, May 30, 1980; 46 FR 8979, Jan. 27, 1981] 5 50.3 Definitions As used in this part: (a) Act means the Federal Food, Drug, and Cosmetic Act, as amended (sees. 201-902, 52 Stat. 1040 et seq. as amended (21 USC 321-392)). (b) Application for research or marketing permit...
309. 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.