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Halcion: An Independent Assessment of Safety and Efficacy Data F Consent to Disclosure For the purposes of this study, Pharmacia and Upjohn, Inc., agreed to disclose all pertinent information to the IOM Committee. A copy of their consent agreement follows.
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Halcion: An Independent Assessment of Safety and Efficacy Data Consent to Disclosure On behalf of Pharmacia & Upjohn Company, I hereby consent to disclosure of the following documents by the United States Food and Drug Administration (FDA) to the Institute of Medicine at the National Academy of Science (IOM) for the purpose of performing an independent review of the data. I understand that the documents as disclosed to IOM may contain trade secrets and confidential commercial or financial information within the meaning of 18 U.S.C. 1905, 21 U.S.C. 331(j) and 5 U.S.C. 552(b)(4) and agree to hold FDA harmless for any injury caused by FDA's disclosing the documents to IOM. IOM is authorized to include any portion of any document so disclosed, as well as any description or summary of any document so disclosed, in a report to be made available to the public by IOM at the conclusion of the independent review. Documents to be disclosed: NDA Clinical Trial Data FDA's medical reviews of the NDA Complete study reports (Upjohn) for the three pivotal premarketing studies (6024, 6045, 6041) Complete study reports (Upjohn) for the three major postmarketing studies (0366, 0373, 0235) Case report forms/line listings for the clinical trials (i.e., new data) 1992 Re-Analysis FDA Report on the Database remake and re-analysis of 1992 Annual Reports The last 10 annual reports for the NDA 1996 Task Force Report The task force report (including Dr. Williams' regulatory history of the NDA) Statistics & Epidemiology All reports on Halcion from FDA Office of Epidemiology & Biostatistics
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Halcion: An Independent Assessment of Safety and Efficacy Data Medical Literature The medical literature cited in the task force report Other Transcripts and minutes of the three advisory committee meetings on the drug FDA's Biopharmaceutic reviews of the NDA We understand that physicians' and patients' names will not be disclosed to the public. Kenneth F. King, Ph.D. Vice President, Regulatory Affairs Pharmacia & Upjohn Company Date
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