Promotion of Drugs and Medical Devices for Unapproved Uses: Hearing Before the Human Resources and Intergovernmental Relations Subcommittee of the Committee on Government Operations, House of Representatives, One Hundred Second Congress, First Session, June 11, 1991, Volume 4U.S. Government Printing Office, 1992 - 395 pages |
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abrasive acne adverse drug adverse events adverse reactions agency autoimmune autoimmune disease believe breast implants Center Chairman Collagen Corporation collagen injections concerns CONGRES CONGRESS THE LIBRARY consumers correct cosmetic Dermatology dermatomyositis disease Dow Corning Drug Administration editors expenses incurred Honorarium expenses incurred Reimbursement exposure facial FDA's files Food and Drug Honorarium and reimbursement Honorarium Reimbursement implants injectable collagen investigation isotretinoin issues JAMA KESSLER labeling letter LIBRARY OF CONGRESS lip augmentation liquid injectable silicone liquid silicone LUNDBERG manufacturer manuscript MDR report medical devices Medical Journal meeting migraine Orentreich patients percent pharmaceutical Photodamage Study physicians placebo PM/DM polymyositis prescription drug promotion questions received regulation regulatory Reimbursement for expenses response RESS Retin Retin-A Retinoids risk Rockville scars scientific silicone injections statement subcommittee sumatriptan surgery teratogenicity tion tissue Topical Retinoids treated treatment tretinoin unapproved Update Symposium WEISS wrinkles Zyderm Zyplast
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Page 109 - Authorship All persons designated as authors should qualify for authorship. Each author should have participated sufficiently in the work to take public responsibility for the content.
Page 74 - ... which does not achieve any of its principal intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its principal intended purposes.
Page 154 - DEPARTMENT OF HEALTH AND HUMAN SERVICES BEFORE THE SUBCOMMITTEE ON HUMAN RESOURCES AND INTERGOVERNMENTAL RELATIONS COMMITTEE ON GOVERNMENT OPERATIONS US HOUSE OF REPRESENTATIVES JUNE 4, 1992 FOR RELEASE ONLY UPON DELIVERY Good Morning Mr.
Page 74 - Pharmacopeia, or any supplement to them, (2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals...
Page 113 - ... basis. Such an error should not be confused with inadequacies exposed by the emergence of new scientific information in the normal course of research. The latter require no corrections or withdrawals. The second type of difficulty is scientific fraud. If substantial doubts arise about the honesty of work, either submitted or published, it is the editor's responsibility to ensure that the question is appropriately pursued (including possible consultation with the authors).
Page 123 - The TIMI Study Group. Comparison of invasive and conservative strategies after treatment with intravenous tissue plasminogen activator in acute myocardial infarction. Results of the Thrombolysis in Myocardial Infarction (TIMI) Phase II trial.
Page 118 - ... will usually discuss with the authors the manner in which such information is to be communicated to the reader. Because the essence of reviews and editorials is selection and interpretation of the literature, the Journal expects that authors of such articles will not have any financial interest in a company (or its competitor) that makes a product discussed in the article.
Page 153 - We appreciate your continued interest in these issues, and I will be happy to answer questions. [The prepared statement of Hon.
Page 113 - Nevertheless, two types of difficulty may arise. First, errors may be noted in published articles that require the publication of a correction or erratum of part of the work. It is conceivable that an error could be so serious as to vitiate the entire body of the work, but this is unlikely and should be handled by editors and authors on an individual basis. Such an error should not be confused with inadequacies exposed by the emergence of new scientific information in the normal course of research....