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 103
... reimbursement problems , especially in the oncology area where greater than 50 percent of uses are off - label . Also , it is an ongoing issue for pediatricians ( and includes liability concerns as well as medical concerns ) because 70 ...
... reimbursement problems , especially in the oncology area where greater than 50 percent of uses are off - label . Also , it is an ongoing issue for pediatricians ( and includes liability concerns as well as medical concerns ) because 70 ...
Page 104
... reimbursement issue for off - label use , are attempting to develop useful alternatives to the traditional , time - consuming and costly supplemental NDA ( which pharmaceutical companies are reluctant to file if recovery of their ...
... reimbursement issue for off - label use , are attempting to develop useful alternatives to the traditional , time - consuming and costly supplemental NDA ( which pharmaceutical companies are reluctant to file if recovery of their ...
Page 139
... reimbursement for the collagen . A dermatologist wrote to Collagen Corp on February 4 asking the company to reconsider the promotion in light of the AMA's guidelines . A copy was sent to the AMA's Council on Ethical and Judicial Affairs ...
... reimbursement for the collagen . A dermatologist wrote to Collagen Corp on February 4 asking the company to reconsider the promotion in light of the AMA's guidelines . A copy was sent to the AMA's Council on Ethical and Judicial Affairs ...
Page 224
... reimbursed for providing the service of adverse drug event reporting 5. I have a professional obligation to report adverse ( 1.0 ) 3.3 ( 0.9 ) 1.5 ( 0.8 ) drug events 6. If I report an 3.1 adverse drug ( 0.9 ) event , I increase my own ...
... reimbursed for providing the service of adverse drug event reporting 5. I have a professional obligation to report adverse ( 1.0 ) 3.3 ( 0.9 ) 1.5 ( 0.8 ) drug events 6. If I report an 3.1 adverse drug ( 0.9 ) event , I increase my own ...
Page 225
... reimbursement for a behavior that they clearly considered a professional obligation . Respondents did not perceive reporting as increasing their own liability . There was no great concern about being involved with additional government ...
... reimbursement for a behavior that they clearly considered a professional obligation . Respondents did not perceive reporting as increasing their own liability . There was no great concern about being involved with additional government ...
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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.