FDA/NIH Reference Materials

The following documents and websites provide reference material about FDA and NIH regulation of regenerative medicine.

Pre-IND meetings

For information about pre-IND meetings as well as other types of regulatory meetings with the FDA, please see the following documents:

Interested parties may contact Dr. Patrick Riggins, Ph.D., Branch Chief, Regulatory Management Staff, at 301-827-5366, or Patrick.Riggins@fda.hhs.gov for any questions related to early meetings, pre-IND meetings or other types of regulatory meetings with OCTGT.

Past Presentations

FDA & NIH Website Links

Guidance documents

Advisory committee documents