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, 1990 - 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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Common terms and phrases
acid active ingredients amdinocillin amended ampicillin antibiotic antibiotic drug approved assay azlocillin bacitracin batch bioavailability bioequivalence buffer carbenicillin Center for Drug centimeters certification chapter chromatograph clindamycin clinical investigation Commissioner control number cyclacillin dicloxacillin digoxin dilute distilled water dosage form dose Drug Administration drug application drug prod drug product FEDERAL REGISTER flask Food and Drug grams graph hearing hydrochloride insulin investigational new drug labeling manufacturer marketing master standard means a specific ment methods micrograms milligrams milliliter misbranded mobile phase monograph neomycin obtain OTC drug packaged patient peak penicillin percent phosphate potassium potency preparation procedures Proceed as directed products containing protocol reagent request safe and effective safety sample solution sodium specific lot sponsor standard solution standards of identity statement sterile submitted Subpart substances produced suitable tablets tetracycline therapeutic moiety ticarcillin tion titration warning zinc
Popular passages
Page 129 - 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,...
Page 88 - The research protocol should always contain a statement of the ethical considerations involved and should indicate that the principles enunciated in the present Declaration are complied with.
Page 209 - 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.
Page 88 - Research) 1. In the purely scientific application of medical research carried out on a human being, it is the duty of the doctor to remain the protector of the life and health of that person on whom blomedical research is being carried out.
Page 118 - ... drug are inadequate to assure and preserve its identity, strength, quality, and purity and were not made adequate within a reasonable time after receipt of written notice from the...
Page 88 - In case of legal incompetence, informed consent should be obtained from the legal guardian in accordance with national legislation. Where physical or mental incapacity makes it impossible to obtain informed consent, or when the subject is a minor, permission from the responsible relative replaces that of the subject in accordance with national legislation. Whenever the minor child is in fact able to give a consent, the minor's consent must be obtained in addition to the consent of the minor's legal...
Page 80 - ... (2) Curriculum vitae. A curriculum vitae or other statement of qualifications of the investigator showing the education, training, and experience that qualifies the investigator as an expert in the clinical investigation of the drug for the use under investigation. (3) Clinical protocol, (i) For Phase 1 investigations, a general outline of the planned investigation including the estimated duration of the study and the maximum number of subjects that will be involved. (ii) For Phase 2 or 3 investigations,...
Page 175 - 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).
Page 88 - Declaration should not be accepted for publication. 9. In any research on human beings, each potential subject must be adequately informed of the aims, 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...
Page 88 - ... it offers hope of saving life, reestablishing health, or alleviating suffering. 2. The potential benefits, hazards, and discomfort of a new method should be weighed against the advantages of the best current diagnostic and therapeutic methods. 3. In any medical study, every patient— including those of a control group, if any— should be assured of the best proven diagnostic and therapeutic method.