Code of Federal Regulations: 2000-U.S. General Services Administration, National Archives and Records Service, Office of the Federal Register, 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 87.
6. lappuse
... person includes individ- uals , partnerships , corporations , and associations . ( f ) The definitions and interpreta- tions of terms contained in section 201 of the act shall be applicable to such terms when used in the regulations in ...
... person includes individ- uals , partnerships , corporations , and associations . ( f ) The definitions and interpreta- tions of terms contained in section 201 of the act shall be applicable to such terms when used in the regulations in ...
8. lappuse
... persons with an interest in a product that is identical , related , or similar to a drug listed in a drug effi- cacy ... person may request an opin- ion on the applicability of such a no- tice to a specific product by writing to the Food ...
... persons with an interest in a product that is identical , related , or similar to a drug listed in a drug effi- cacy ... person may request an opin- ion on the applicability of such a no- tice to a specific product by writing to the Food ...
10. lappuse
... person . Any interested person may file a petition seeking such exemption , which petition may be pursuant to part 10 of this chapter , or in the form of a supplement to an approved new drug application . ( c ) New drug status of drugs ...
... person . Any interested person may file a petition seeking such exemption , which petition may be pursuant to part 10 of this chapter , or in the form of a supplement to an approved new drug application . ( c ) New drug status of drugs ...
18. lappuse
... person , pur- suant to part 10 of this chapter . Prior to issuance of such a proposal , the ap- plicant will be provided an opportunity for a conference with representatives of the Food and Drug Administration . When appropriate ...
... person , pur- suant to part 10 of this chapter . Prior to issuance of such a proposal , the ap- plicant will be provided an opportunity for a conference with representatives of the Food and Drug Administration . When appropriate ...
19. lappuse
... person's ability to conduct normal life functions . Life - threatening adverse drug experi- ence . Any adverse drug experience that places the patient , in the view of the initial reporter , at immediate risk of death from the adverse ...
... person's ability to conduct normal life functions . Life - threatening adverse drug experi- ence . Any adverse drug experience that places the patient , in the view of the initial reporter , at immediate risk of death from the adverse ...
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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 26002699) XXVII Office of Information Resources Management, Department of Agriculture (Parts 27002799) XXVIII Office of Operations, Department of Agriculture (Parts 2800 2899) XXIX Office of Energy, Department of Agriculture (Parts 29002999) XXX Office of the Chief Financial Officer, Department of Agriculture (Parts 30003099) XXXI Office of Environmental Quality, Department of Agriculture (Parts 31003199) 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.