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Regulatory Compliance and Human Subjects Protection Branch (RCHSPB)

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Regulatory Group

In support of investigational new drug (IND) applications, the Regulatory Group:

  • Prepares and submits new IND applications and serial submissions
  • Prepares IND annual progress reports; assists investigators with writing Investigator Brochures
  • Reviews protocols to ensure that they comply with FDA regulations, Good Clinical Practice (GCP) guidelines, and NIH policy
  • Acts as a liaison between the Principal Investigator and the Food and Drug Administration (FDA)

Last Updated February 07, 2008