Clinical Trial Development: A Focus on Publication of Trial Information at The Sixth Annual Pharmaceutical Compliance Congress and Best Practices Forum. Mark S. Brown Margaret K. Feltz November 7-9, 2005 Washington, D.C. *The comments and opinions expressed herein are the authors’ only and
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Clinical Trial Development: A Focus on Publication of Trial InformationatThe Sixth Annual Pharmaceutical Compliance Congress and Best Practices Forum
Mark S. Brown
Margaret K. Feltz
November 7-9, 2005
*The comments and opinions expressed herein are the authors’ only and
should not be attributed to King and Spaulding or Purdue Pharma L.P.
* JAMA, NEJM, New Zealand Medical Journal, Norwegian Med. J., CMAJ, The Lancet, National Library of Medicine, Annals of Internal Med, Croatian Med. J., Dutch Journal of Med., J. of the Danish Med. Assoc., Annals of Internal Med., The Med. J. of Australia
* Industry groups include European Federation of Pharmaceutical Industries & Associations, International Federation of Pharmaceutical Manufacturers and Associations, Japanese Pharmaceutical Manufacturers Association and Pharmaceutical Research & Manufacturers of America
* FDA defines a clinical investigation as “any experiment in which a drug is administered or dispensed to, or used involving, one ore more human subjects. … [A]n experiment is any use of a drug except for the use of a marketed drug in the course of medical practice.” 21 C.F.R. § 312.3(b).
“[The industry is] doing this because [it] recognizes that sometimes what the law requires doesn’t give patients all they need. Patients – both those with manageable conditions and those who are gravely ill – need information about new drugs that are being tested.”
Dr. Larry Hirsch
Merck Executive Director, Medical Communications
Mark S. Brown Information
King & Spaulding LLP
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Margaret K. Feltz
Purdue Pharma L. P.
One Stamford Forum
Stamford, CT 06901
P: (203) 588-8754
F: (203) 588-6269
Web: www.pharma.comOur Contact Information