Orphan Drug Development

Orphan Drug Development | Episode 01- What is Orphan Drug? | Rare Disease | Drug Regulatory Affairs

Orphan Drugs: An Introduction

Healthcare Triage

What are Orphan Medicines? - Video explainer

European Medicines Agency

Orphan Drug Development, Pricing, and Access

Orphan Drug Development | Episode 05 - How to get Orphan Drug Designation in USA | USFDA | DRA

Orphan drug development and epilepsy with Ana Mingorance

Video Journal of Biomedicine

Orphan Drug Development | Episode 06 - USFDA vs EMA : Orphan Drug Designation | Regulatory Affairs

Orphan Drug Development | Episode 04 - How to get Orphan Drug Designation in European Union | DRA

Session I: Regulatory Compliance: A Complex but Essential Component in the Pharmaceutical Industry

Orphan Drug Development | Episode 07 - How to get Orphan Drug Designation in Japan | MHLW | DRA

The Orphan Drug Act is Just One Factor in Orphan Drug Development

Improving Regulatory and Operational Performance in Orphan Drug Development

Premier Research

What are the development challenges specific to orphan medicines?

Meet the Authors: Orphan Drug Development for Rare Diseases

Regulatory Affairs Professionals Society

Orphan Drug Development | Episode 02- What is Orphan Drug Designation? | Drug Regulatory Affairs

Orphan Drug Development | Episode 03- Benefits and Incentives for Orphan Drug Development | DRA

What Everyone Affected by a Rare Disease Should Know About the Orphan Drug Act

National Organization for Rare Disorders (NORD)

Patients Matter: FDA’s Office of Orphan Products Development Grants Programs

U.S. Food and Drug Administration

Some Advice for Developing Orphan Drugs

Rare Disease Report

FDA Orphan Drugs Program and Financial Incentives for CDER Medical Products- June 10, 2019

U.S. Food and Drug Administration