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Halcion An Independent Assessment of Safety and Efficacy Data (1997) / Chapter Skim
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Appendix F: Upjohn Consent to Disclosure
Pages 150-152

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From page 150...
... F Consent to Disclosure For the purposes of this study, Pha~macia and Upjohn, Inc., agreed to disclose all pertinent information to the TOM Committee. A copy of their consent agreement follows.
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From page 151...
... The last 10 annual reports for Tic NDA ~'= 7. The task force report (including Dr.
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From page 152...
... Transcripts and minutes of die three advisory committee meetings on the drug I 1. FDA's Biophanneceutic reviews of Me NDA We underhand that physicians' and patients' names will not be disclosed to the public.
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  • task force
  • independent review
  • annual reports

  • advisory committee
  • clinical trials
  • including dr
  • database remake
  • fda office

  • fda report
  • nda complete


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