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.
Heather Cronin, MSc
Manager, Research Regulatory Affairs & Quality Assurance Unit