Code of Federal Regulations: Containing a Codification of Documents of General Applicability and Future Effect as of December 31, 1948, with Ancillaries and IndexU.S. General Services Administration, National Archives and Records Service, Office of the Federal Register, 1976 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
0.1M potassium phosphate 100 milliliters accurately weighed acid ampicillin antibiotic application bacitracin batch for potency carbenicillin cephalexin chapter Chlortetracycline Commissioner crystalline penicillin described in paragraph dicloxacillin directed in paragraph distilled water dosage forms dose Drug Administration Food and Drug Further dilute gentamicin give a stock grams hetacillin hydrochloride immediate containers ingredient insulin labeling master standard methadone methods of assay-(1 microbiological agar diffusion micrograms milligrams milligrams per milliliter milliliter milliliter estimated millimeters minocycline mycin nafcillin neomycin neomycin sulfate new-drug number of milligrams oral oxacillin Oxytetracycline packages patient polymyxin potassium phosphate potassium phosphate buffer preparing the sample Proceed as directed purity reference concentration represented to contain request shall contain Requests for certification Requirements for certification Results of tests safety Samples required sodium solu Standards of identity stock solution streptomycin submitted Subpart suspension tablets tainer taining tests and assays Tests and methods tests except sterility tetracycline tion titration volumetric flask
Popular passages
Page 67 - 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 64 - CLINICAL RESEARCH 1 . In the purely scientific application of clinical 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 clinical research is being carried out.
Page 87 - Documentary evidence not submitted in advance in accordance with the requirements of paragraphs (a) and (b) of this section shall not be received in evidence in the absence of a clear showing that the offering party had good cause for his failure to produce the evidence sooner. (d) The authenticity of all documents...
Page 73 - Information for use, including Indications, effects, dosages, routes, methods, and frequency and duration of administration, and any relevant hazards, contraindications, side effects, and precautions, under which practitioners licensed by law to administer the drug can use the drug for the purposes for which it Is Intended, Including all purposes for which it is to be advertised, or represented...
Page 59 - The investigator certifies that he will inform any patients or any persons used as controls, or their representatives, that drugs are being used for investigational purposes, and will obtain the consent of the subjects, or their representatives, except where this is not feasible or, in the investigator's professional judgment, is contrary to the best interests of the subjects.
Page 56 - ... application is approved for the drug; or, if an application is not approved, until 2 years after shipment and delivery of the drug for investigational use is discontinued and the Food and Drug Administration has been so notified. Upon the request of a scientifically trained and properly authorized employee of the Department at reasonable times, the sponsor makes the records referred to in this subparagraph and in...
Page 18 - Secretary finds (1) that the applicant has failed to establish a system for maintaining required records, or has repeatedly or deliberately failed to maintain such records or to make required reports, in accordance with a regulation or order under...
Page 67 - The application must be signed by the applicant or by an authorized attorney, agent, or official. If the applicant or such authorized representative does not reside or have a place of business within the United States, the application must also furnish the name and post office address of, and must be countersigned by, an authorized attorney, agent, or official residing or maintaining a place of business within the United States.
Page 54 - Information from precllnlcal and clinical investigations and experience with Its components, Including all reports available to the sponsor suggesting side-effects, contraindications, and Ineffectiveness in use of such components: Such summary should Include an adequate bibliography of publications about the components and may Incorporate by reference any Information concerning such components previously submitted by the sponsor to the Food and Drug Administration. Include a statement of the expected...
Page 67 - ... and packaging of the drug are adequate to preserve its identity, strength, quality, and purity in conformity with good manufacturing practice and identifies each establishment, showing the location of the plant conducting these operations.) 9. Samples of the drug and articles used as components, as follows: a. The following samples shall be submitted with the application or as soon thereafter as they become available. Each sample shall consist of four identical, separately packaged subdivisions,...