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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Page 2
... scars but not for the lip enlargements that are the current fad . All of these drugs and devices are widely available because they are approved for other uses . Although we are focusing on three examples , the issues we will discuss are ...
... scars but not for the lip enlargements that are the current fad . All of these drugs and devices are widely available because they are approved for other uses . Although we are focusing on three examples , the issues we will discuss are ...
Page 7
... scarring might occur , but he assured me that it would not on such short- term use . I became totally traumatized as the time went on and I noticed no change in my appearance . My weight dropped to 89 pounds , and I started having ...
... scarring might occur , but he assured me that it would not on such short- term use . I became totally traumatized as the time went on and I noticed no change in my appearance . My weight dropped to 89 pounds , and I started having ...
Page 10
... scarring might occur , but he assured me that it would not on such short term use . I I became totally traumatized as the time went on , and I noticed no change in my appearance . My weight dropped to 89 lbs . , and I started having ...
... scarring might occur , but he assured me that it would not on such short term use . I I became totally traumatized as the time went on , and I noticed no change in my appearance . My weight dropped to 89 lbs . , and I started having ...
Page 22
... scarring , a reduction in my vision , and glaucoma . It can be very painful and can cause blind- ness . Iritis is treated with cortisone or sometimes with drugs used in cancer chemotherapy . There have been times when I have needed to ...
... scarring , a reduction in my vision , and glaucoma . It can be very painful and can cause blind- ness . Iritis is treated with cortisone or sometimes with drugs used in cancer chemotherapy . There have been times when I have needed to ...
Page 23
... scar tissue and possible in the areas where the silicone had been injected . Much of the silicone can never be ... scars and left me with nerve damage . Removing some of the silicone did , however , reduce the frequency and extent ...
... scar tissue and possible in the areas where the silicone had been injected . Much of the silicone can never be ... scars and left me with nerve damage . Removing some of the silicone did , however , reduce the frequency and extent ...
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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.
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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.