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How to Get an FDA Orphan Drug Designation
By: Christine Clarke, PhD, Senior Global Regulatory Affairs Manager
New FDA Guidance to Support Ultra-Rare Disease Drug Development
by Dr. Amanda Beaster, Senior Manager of Regulatory Strategy Antisense oligonucleotide ...
FDA Expedited Program Designations to Support Rare Disease Drug Development
By: Christine Clarke PhD, Senior Medical Writer One in 10 Americans is affected by rare diseases—more than ...
Challenges of Rare Disease Drug Development Programs
By: Amanda Beaster, Ph.D.
How #OneMMS Actively Supports Rare Disease Day
Rare diseases are often overlooked, but they affect many individuals. There may be as many as 7,000 rare ...