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, 1986 Special edition of the Federal Register, containing a codification of documents of general applicability and future effect ... with ancillaries. |
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52 Stat acid act is approved adequate directions amended amphetamines antibiotic application pursuant approved new drug batch beling bioavailability bioequivalence chapter chloride Claimed Investigational Exemption clear warning statement clinical investigations Commissioner containing no drug Cosmetic Act dextroamphetamine digoxin dose Drug Administration drug application drug limited drug prod drug product estrogen Federal Food FEDERAL REGISTER Food and Drug goxin gram human hydrochloride ingredient insert trade name insulin Intrauterine devices IUD's labeled with adequate labeling bears manufacturer marketed master standard means a specific meet their professed ment milligrams milliliter misbranded name of drug Notice of Claimed package paragraph patient labeling percent physician potency pregnancy preparation contains preparation is labeled preparations meeting professed standards pursuant to section radioactive drug recognized as safe request safe and effective safety sodium sponsor standards of identity studies submitted Subpart tion United States Pharmacopeia
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56. 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,...
61. lappuse - ACETAMINOPHEN (N-ACETYL-pAMINOPHENOL) (See §310.201(a)(l) of this chapter.) Warning — Do not give to children under 3 years of age or use for more than 10 days unless directed by a physician. 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.
35. lappuse - BASIC PRINCIPLES 1 . Biomedical research involving human subjects must conform to generally accepted scientific principles and should be based on adequately performed laboratory and animal experimentation and on a thorough knowledge of the scientific literature. 2. The design and performance of each experimental procedure involving human subjects should be clearly formulated in an experimental protocol which should be transmitted to a specially appointed independent committee for consideration, comment...
35. lappuse - 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.
35. lappuse - 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.
26. lappuse - A statement of the methods, facilities, and controls used for the manufacturing, processing, and packing of the new drug to establish and maintain appropriate standards of identity, strength, quality, and purity as needed for safety and to give significance to clinical investigations made with the drug.
46. lappuse - ... when the application was approved, the methods used in, or the facilities and controls used for, the manufacture, processing, and packing of...
82. lappuse - ... of the act if shipped or sold to, or in the possession of, persons regularly and lawfully engaged in instruction in pharmacy, chemistry, or medicine not involving clinical use; or in law enforcement; or in research not involving clinical use; or in chemical analysis or physical testing, provided they are to be used only for such instruction, law enforcement, research, analysis, or testing, and provided further that their labels bear the statement "Not for drug use.
xv. lappuse - New drug substance" means any substance that when used in the manufacture, processing, or packing of a drug, causes that drug to be a new drug, but does not include intermediates used in the synthesis of such substance. (h) The newness of a drug may arise by reason (among other reasons) of: (1) The newness for drug use of any substance which composes such drug, in whole or in part, whether it be an active substance or a menstruum, excipient, carrier, coating, or other component. (2) The newness for...
57. lappuse - Conspicuousness of •warning statements. Necessary warning statements should appear in the labeling prominently and conspicuously as compared to other words, statements, designs, and devices, and in bold type on clearly contrasting background, in order to comply with the provisions of section 502(c) and (f)(2) of the act.