Zdrowie i gospodarka · 15/01/2008

FDA Requests Public Comment on Proposed Collection of Information for Orphan Drugs

The Food and Drug Administration (FDA) is seeking public input on a proposed collection of information related to orphan drugs, which are medications developed for rare diseases, and the application process for orphan medicinal product designation, as outlined in the Orphan Drug Act and a joint application form with the European Medicines Agency (EMA).