Orphan Drug Designation Guidance

The Orphan Minute Series with Dr. Cote

The Orphan Minute features 60-second insights from Dr. Tim Cote, former FDA OOPD Director, sharing expert guidance on FDA orphan drug expectations, the ODD review process, PRV pathways, and the strategic choices that help sponsors avoid costly delays. Each video distills decades of regulatory experience into practical, bite-sized tips you can use immediately when preparing your first, or next, designation request.

Explore more articles on these topics in our Orphan Drug Insights Journal and follow Only Orphans Cote on LinkedIn for regular updates, new episode releases, and essential guidance for teams pursuing orphan designation or planning rare-disease development globally.

Orphan Drug Designation Basics

Orphan Drug Designation Guidance

The Orphan Minute Series with Dr. Cote

Orphan Drug Designation Basics

FDA Process, Regulatory Pathway, & Common Pitfalls

Prevalence, Epidemiology, & Evidence Requirements

Priority Review Vouchers & FDA Incentives

Additional FDA Pathways & Designations

Industry Insights, Global Updates, & Announcements

Led by the former Director of the FDA Office of Orphan Products Development (OOPD) and a dedicated staff including a former FDA OOPD reviewer, Only Orphans Cote provides unparalleled orphan designation consulting service that will get your rare disease drug to market.