Code of Federal Regulations: Containing a Codification of Documents of General Applicability and Future Effect as of December 31, 1948, with Ancillaries and Index
Special edition of the Federal Register, containing a codification of documents of general applicability and future effect ... with ancillaries.
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abbreviated acid active ingredients added addition Administration Adults adverse agency amended appropriate approval Authority citation cation chapter claim clinical combination conducted consult copy corrected Department described designation determination directed disease doctor dosage dosage form dose drug application drug product effective established Evaluation exceed experience Federal Food and Drug heading hearing human hydrochloride identified identity indications initial intended investigation labeling listed listed drug manufacturer marketing means meet ment method milligrams notice obtain Office oral OTC drug paragraph patent percent period person preparation prevention procedures prod products containing proposed protocol reasons reference regulations removed request Research revised safe safety Service solution specific sponsor standards statement submission submitted Subpart tion treatment United unless warning
6. 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.