Table 3.

FDA resources, guidance, and advice for ODD and RPDD applications

Topic	Information Source
General advice	OOPD website: FAQs35
How to submit ODD request	OOPD website19
Recommended Tips for Creating an Orphan Drug Designation Application	Webinar32 script33 and slides31
Meetings with OOPD	Guidance52
ODD Waivers, Reductions, and Refunds	Guidance12
FDA OOPD Grants	OOPD website: Orphan Products Grant Program53
Rare Pediatric Disease Priority Review Voucher Program	Guidance17
Pediatric Subpopulations of Common Diseases	Guidance54
Interpreting Sameness of Gene Therapy Products Under the OD Regulations	Guidance20

URLs for the websites cited in the table are included in the right column as well as available in the reference list.

FAQ, Frequently Asked Question, OD, Orphan Drug.