Drugs

Rare Diseases

Below is a sortable table of Rare Diseases Guidances

CategoryTitleTypeDate
Draft guidance for industry on rare pediatric disease priority review vouchers Rare Pediatric Disease Priority Review Vouchers, Draft Guidance for Industry 11/17/14
Rare Diseases Rare Diseases: Common Issues in Drug Development Guidance for Industry (PDF - 306KB) Draft Guidance 08/14/15
Rare Diseases Pediatric Rare Diseases--A Collaborative Approach for Drug Development Using Gaucher Disease as a Model; Draft Guidance for Industry (PDF - 262KB) Draft Guidance 12/06/17

Page Last Updated: 12/06/2017
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