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 4
... FDA's rights and responsibilities to monitor and act upon these problems . The law is clear that FDA is limited to oversight of companies that produce and promote these drugs and devices . The law is equally clear that unless a clear ...
... FDA's rights and responsibilities to monitor and act upon these problems . The law is clear that FDA is limited to oversight of companies that produce and promote these drugs and devices . The law is equally clear that unless a clear ...
Page 75
... FDA concerning the safety of Zyderm and Zyplast Collagen . The report was issued as follows : TEXAS DEPARTMENT OF HEALTH ... FDA's Analysis of the Same Data INTRODUCTION : In July 1989 , Mr. Dennis Baker , Director of the Food and Drug ...
... FDA concerning the safety of Zyderm and Zyplast Collagen . The report was issued as follows : TEXAS DEPARTMENT OF HEALTH ... FDA's Analysis of the Same Data INTRODUCTION : In July 1989 , Mr. Dennis Baker , Director of the Food and Drug ...
Page 80
... FDA'S ANALYSIS AND ITS MAJOR METHODOLOGICAL FLAWS : In their analysis , the FDA utilized data from a company survey of 109 physicians , regarding the length of time that collagen recipients are followed by their respective physicians ...
... FDA'S ANALYSIS AND ITS MAJOR METHODOLOGICAL FLAWS : In their analysis , the FDA utilized data from a company survey of 109 physicians , regarding the length of time that collagen recipients are followed by their respective physicians ...
Page 81
... FDA included all of the patients who have been treated from July 1980 up through June 1989 . This amounts to approximately ... FDA's assumptions and methods . First of all , we disagree with the use of patient - years of follow - up as a ...
... FDA included all of the patients who have been treated from July 1980 up through June 1989 . This amounts to approximately ... FDA's assumptions and methods . First of all , we disagree with the use of patient - years of follow - up as a ...
Page 89
... FDA has granted Collagen no exemption from reporting . On the contrary , Collagen is one of many firms that FDA has approved to submit MDR reports under an alternative reporting plan . FDA's approval of an alternative reporting plan for ...
... FDA has granted Collagen no exemption from reporting . On the contrary , Collagen is one of many firms that FDA has approved to submit MDR reports under an alternative reporting plan . FDA's approval of an alternative reporting plan for ...
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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
Popular passages
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.