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Comments Sought on Orphan Drug Procedures Info

06/12/2013

Federal Register Notice: FDA seeks comment on the proposed collection of information on the procedures by which sponsors of orphan drugs may request eligibility for the incentives by implementing a program as outlined in the Orphan Drug Act and the joint adoption by FDA and the European Medicines Agency (EMA) of the Common EMA/FDA Application Form for Orphan Medicinal Product Designation (Form FDA 3671). Comments should be submitted by 8/12. To view this notice, click here.

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