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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... meeting with Dr. Al Kligman , regarding aging skin , and article from Journal of Ameri- can Association dated November 14 , 1990 , entitled " The Federal Regulation of Prescription Drug Advertising and Promotion " . Memorandum dated ...
... meeting with Dr. Al Kligman , regarding aging skin , and article from Journal of Ameri- can Association dated November 14 , 1990 , entitled " The Federal Regulation of Prescription Drug Advertising and Promotion " . Memorandum dated ...
Page 1
... meeting at this very same time that are on my sched- ule alone , so it is a very busy day . The House will be in session , as well . We will try to handle the hearing as expeditiously as we pos- sibly can . Every day , thousands of ...
... meeting at this very same time that are on my sched- ule alone , so it is a very busy day . The House will be in session , as well . We will try to handle the hearing as expeditiously as we pos- sibly can . Every day , thousands of ...
Page 63
... meeting . he was currently monitoring two On July 14 , 1989 , Mr. Baker and Mr. Ken Davis , Division of Food and Drugs , met with other Chief Drug Investigator , Dr. explained the circumstances surrounding the patients he was currently ...
... meeting . he was currently monitoring two On July 14 , 1989 , Mr. Baker and Mr. Ken Davis , Division of Food and Drugs , met with other Chief Drug Investigator , Dr. explained the circumstances surrounding the patients he was currently ...
Page 65
... meeting and subsequent telephone conversations with him . INDEX CASE PRESENTATION : In late July 1983 , Dr. applied the recommended test dose of BSC to his patient · a 40 year old white female . On October 15 , 1983 , after about three ...
... meeting and subsequent telephone conversations with him . INDEX CASE PRESENTATION : In late July 1983 , Dr. applied the recommended test dose of BSC to his patient · a 40 year old white female . On October 15 , 1983 , after about three ...
Page 73
... MEETING WITH FDA On January 4 , 1990 , Texas Department of Health personnel met with personnel from the Food and Drug Administration , Center of Devices and Radiological Health ( CDRH ) at the Piccard Building , Rockville , Maryland ...
... MEETING WITH FDA On January 4 , 1990 , Texas Department of Health personnel met with personnel from the Food and Drug Administration , Center of Devices and Radiological Health ( CDRH ) at the Piccard Building , Rockville , Maryland ...
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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
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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.
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.