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Navigating the FDA Regulatory Requirements

This three-part video series provides an overview of best practices for navigating the regulatory maze of the FDA, including help with complex regulatory requirements for new drug (IND) and device (IDE) development; how to optimize your communication with the FDA for IND and IDE applications; and useful tools and resources necessary for finding successful pathways from discovery to clinical implementation.

Presented by IND/IDE Navigator Heather Hatcher

Heather Hatcher, PhDHeather Hatcher, PhD has spent 25 years as an academic research scientist, where she has been involved in clinical and non-clinical research studies in bone and mineral metabolism, diabetes and obesity, cancer biology, biomedical engineering, and regenerative medicine. Her new passion is helping other translational investigators navigate the complex terrain of the U.S. Food and Drug Administration (FDA). Dr. Hatcher received her PhD in Molecular and Cellular Biology and Pathobiology from the Medical University of South Carolina in Charleston, SC.

Learn more about available IND/IDE Navigation Services


Wake Forest CTSI

Target Audience

  • Faculty
  • Postdoctoral Fellows & Scholars

Delivery Method


RCR Credit

0 Credit(s)



Contact Information

Name: Tom Roth
Phone: 716-8355

Created by: Thomas Roth on 9/9/2016 3:34:20 PM
Modified by: Shannon Pierce on 11/2/2016 8:49:30 AM

For Research Administrators

The Research Administrators meeting provides updates, tips and tricks, and other relevant information. View past presentations.

Be an Academy Scholar

The Clinical and Translational Science Institute is pleased to announce the KL2 Mentored Career Development Award. Chosen scholars will join the Translational Research Academy.