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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... Regulation ; Robert Sheridan , Director , Office of Device Evaluation , Center for De- vices and Radiological Health ; Joseph Arcarese , Director , Office of Training and Assistance ; Margaret Jane Porter , assistant general coun- sel ...
... Regulation ; Robert Sheridan , Director , Office of Device Evaluation , Center for De- vices and Radiological Health ; Joseph Arcarese , Director , Office of Training and Assistance ; Margaret Jane Porter , assistant general coun- sel ...
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... Regulation of Prescription Drug Advertising and Promotion " . Memorandum dated July 26 , 1984 , regarding Orentreich investiga- tion ........ Pamphlet from Collagen Corp. entitled " Injectable Collagen . The end of the lines " Press ...
... Regulation of Prescription Drug Advertising and Promotion " . Memorandum dated July 26 , 1984 , regarding Orentreich investiga- tion ........ Pamphlet from Collagen Corp. entitled " Injectable Collagen . The end of the lines " Press ...
Page 4
... regulations that affect these decisions . FDA can determine specific uses for the drugs and devices , and it can dictate how the producers can promote the products . FDA can not interfere in the private practice of medicine between ...
... regulations that affect these decisions . FDA can determine specific uses for the drugs and devices , and it can dictate how the producers can promote the products . FDA can not interfere in the private practice of medicine between ...
Page 6
... regulatory structure . Thank you , Mr. Chairman . Mr. WEISS . Thank you very much , Mr. Payne . We will be enter- ing other statements into the record , without objection , and other documents , as we proceed . Our first panel will ...
... regulatory structure . Thank you , Mr. Chairman . Mr. WEISS . Thank you very much , Mr. Payne . We will be enter- ing other statements into the record , without objection , and other documents , as we proceed . Our first panel will ...
Page 26
... regulations may be completely appropriate . We are talking about the use of a product in the context of cosmetic treatment , and I cannot think of even one reason why its use should be allowed unless and until those selling it or using ...
... regulations may be completely appropriate . We are talking about the use of a product in the context of cosmetic treatment , and I cannot think of even one reason why its use should be allowed unless and until those selling it or using ...
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Common terms and phrases
acne activities adverse events adverse reactions advertising agency allergic associated autoimmune disease believe birth defect breast implants Chairman clinical Collagen Corporation collagen injections concerns consumers correct cosmetic Department of Health Dermatology dermatomyositis doctors Dow Corning Drug Administration editors evaluation expenses incurred Honorarium expenses incurred Reimbursement facial FDA approval FDA's files follow-up Food and Drug Honorarium Honorarium Reimbursement indication injectable collagen investigation isotretinoin issues JAMA Journal Kessler labeling letter lip augmentation liquid injectable silicone LUNDBERG manufacturer MDR report medical devices migraine Orentreich package insert patients PAYNE percent pharmaceutical physicians placebo PM/DM polymyositis promotion questions received regulatory Reimbursement for expenses requested response Retin-A Retinoids risk Rockville safety and effectiveness scars scientific SHERIDAN silicone injections skin sponsor statement subcommittee submitted sumatriptan surgery Symposium syndrome Ted Weiss teratogenicity tion tissue Topical Retinoids treated treatment tretinoin unapproved WEISS wrinkles
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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 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 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 153 - We appreciate your continued interest in these issues, and I will be happy to answer questions. [The prepared statement of Hon.
Page 111 - Pharmacology, except as described in an attachment. Furthermore, I attest that I shall produce the data on which the manuscript is based for examination by the editors or their assignees should they request it.
Page 113 - Owners and editors of medical journals have a common endeavor - the publication of a reliable and readable journal, produced with due respect for the stated aims of the journal and for costs. The functions of owners and editors, however, are different. Owners have the right to appoint and dismiss editors and to make important business decisions in which editors should be involved to the fullest extent possible. Editors must have full authority for determining the editorial content of the journal....
Page 6 - The gentleman from New Jersey, Mr. Payne. Mr. PAYNE. Thank you very much, Mr. Chairman.
Page 111 - I certify that any affiliations with or involvement (either competitive or amiable) in any organization or entity with a direct financial interest in the subject matter or materials discussed in the manuscript (eg employment, consultancies, stock ownership, honoraria, expert testimony, etc.) are noted below.