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  1. Clinical Trials and Human Subject Protection

Good Clinical Practice Contacts

Office of Good Clinical Practice (OGCP)

Contact the Office of Good Clinical Practice if you have:

How to contact the Office of Good Clinical Practice

Submit questions via email, in writing, or direct them to our general telephone number. We try to respond to each question as soon as possible.

(Please note: FDA cannot comment about products that are in the review process. We cannot comment about clinical trials for specific products, diseases, or conditions. We cannot answer questions about when a new product subject to pre-market approval will be approved or not approved.)

E-mail: gcp.questions@fda.hhs.gov
Telephone: 301-796-8340
Facsimile: 301-847-8640
Write:
Food and Drug Administration
Office of Good Clinical Practice
Office of Clinical Policy and Programs
10903 New Hampshire Ave., WO32-5103
Silver Spring, MD 20993


Members of our staff:

  • Joanne R. Less, Ph.D., Director, Office of Good Clinical Practice
  • Sheila Brown, R.N., M.S., Policy Analyst
  • Janet Donnelly, RAC, Policy Analyst
  • Carol Drew, JD, Senior Regulatory Counsel
  • Bridget Foltz, MS, MT(ASCP), Policy Analyst
  • Doreen Kezer, M.S.N., Senior Health Policy Analyst
  • David Markert, JD, Regulatory Counsel
  • Janet Norden, M.S.N., R.N., Senior Regulatory Policy Advisor
  • Kevin A. Prohaska, D.O., M.P.H., Senior Medical Policy Analyst
  • Jeff Ramsay, PMP, Project Manager
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