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 |
From inside the book
Results 1-5 of 76
Page
... problems with Dow Corning study . FDA Memorandum dated September 10 , 1990 , and letter dated Sep- tember 21 , 1990 , describing research problems .... Litigation of Celia Anderson , regarding liquid silicone injections ...
... problems with Dow Corning study . FDA Memorandum dated September 10 , 1990 , and letter dated Sep- tember 21 , 1990 , describing research problems .... Litigation of Celia Anderson , regarding liquid silicone injections ...
Page 3
... . Liquid silicone injections have never been approved by FDA , and its continued use presents the agency , the Congress , the medical community and the general public with serious legal and ethical problems . The second question is 3.
... . Liquid silicone injections have never been approved by FDA , and its continued use presents the agency , the Congress , the medical community and the general public with serious legal and ethical problems . The second question is 3.
Page 4
... problems . The second question is the scope of 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 ...
... problems . The second question is the scope of 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 ...
Page 5
... problem exists ... it clearly does . The question is whether or not FDA has met its responsibilities and obligations under the law . I look forward to the testimony of all of our witnesses today , and thank the Chairman again for ...
... problem exists ... it clearly does . The question is whether or not FDA has met its responsibilities and obligations under the law . I look forward to the testimony of all of our witnesses today , and thank the Chairman again for ...
Page 9
... problems , but particularly in the facial area . I am also extremely upset that this drug has caused me to lose 21⁄2 years of normal activities in my life . I feel very strongly that drugs should be tested and researched much more ...
... problems , but particularly in the facial area . I am also extremely upset that this drug has caused me to lose 21⁄2 years of normal activities in my life . I feel very strongly that drugs should be tested and researched much more ...
Other editions - View all
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
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.