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University of Southern California

Mar 13, 2016 7:30 AM - Mar 16, 2016 5:00 PM

Center for the Health Professionals, 1540 Alcazar Street #140, Los Angeles, CA 90089

Regulatory Affairs: The IND, NDA, and Postmarketing

Session 9: FDA's Actions on the Original IND & Future Amendments

Session Chair(s)

Michael  Hamrell, PhD, RAC

Michael Hamrell, PhD, RAC

President

MORIAH Consultants, United States

  • FDA’s Review of an IND
  • Clinical Holds: Basis for Imposition and Process for Removal

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