IND/IDE Support Core

The Clinical and Translational Research Organization's (CTRO) IND/IDE Support Core is responsible for assisting JHACH investigators with the compilation, delivery, and maintenance of FDA IND/IDE regulatory submissions.

Key services provided are:
  • Assisting with the development and compilation of FDA regulatory filings (e.g., Pre-IND/Type B Meeting briefing packages, sponsor-investigator INDs, sponsor-investigator IDEs, IND exemption requests, etc.);
  • Performing routine IND and IDE file maintenance (e.g., Annual Reports, Information / Protocol Amendments, Safety Reports, Withdraw Requests, etc.);
  • Providing development support of specialized regulatory dossiers such as FDA's Request for Orphan Drug Designation, FDA's Humanitarian Use Designation (HUD), and NIH's Appendix M submission for federally-funded recombinant DNA research;
  • Interacting with FDA and other regulatory agencies as a supporting representative;
  • Liaising with the Johns Hopkins Institute for Clinical and Translational Research as needed.

Contact Us

Heather Cronin, MSc
Manager, Research Regulatory Affairs & Quality Assurance Unit
[email protected]