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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... Collagen Corp ... 139 Prepared statement .. 99 Meader , Nancy , Saunderstown , RI : Prepared statement 10 Solomon ... Injections ” . ( III ) 96 103ST XL 03/94 53-005-00 219 862 GBC Letters , statements , etc. , submitted for the record.
... Collagen Corp ... 139 Prepared statement .. 99 Meader , Nancy , Saunderstown , RI : Prepared statement 10 Solomon ... Injections ” . ( III ) 96 103ST XL 03/94 53-005-00 219 862 GBC Letters , statements , etc. , submitted for the record.
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... Collagen Corp. entitled " Injectable Collagen . The end of the lines " Press release describing the NIH consensus conference conclusions ..... Report dated August 24 , 1990 , regarding limited applications for silicone injections ...
... Collagen Corp. entitled " Injectable Collagen . The end of the lines " Press release describing the NIH consensus conference conclusions ..... Report dated August 24 , 1990 , regarding limited applications for silicone injections ...
Page 2
... Collagen injections are approved for treating wrinkles and acne scars but not for the lip enlargements that are the ... injectable silicone , and collagen ? Two , is FDA adequately regulating promotion of these drugs and devices for ...
... Collagen injections are approved for treating wrinkles and acne scars but not for the lip enlargements that are the ... injectable silicone , and collagen ? Two , is FDA adequately regulating promotion of these drugs and devices for ...
Page 3
... Collagen have only been approved for limited purposes , but have been widely prescribed for other uses . Liquid silicone injections have never been approved by FDA , and its continued use presents the agency , the Congress , the medical ...
... Collagen have only been approved for limited purposes , but have been widely prescribed for other uses . Liquid silicone injections have never been approved by FDA , and its continued use presents the agency , the Congress , the medical ...
Page 4
... injections have never been approved by FDA , yet it is still used in many places around this country . There are even ... Collagen for purposes they know have not received approval . FDA- bashing should not be used as a convenient way to 4.
... injections have never been approved by FDA , yet it is still used in many places around this country . There are even ... Collagen for purposes they know have not received approval . FDA- bashing should not be used as a convenient way to 4.
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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.
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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.