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Generics Bulletin

Medtech Insight

US FDA Should Offer Formal Declaration Of Orphan Drug Flexibility, Attorney Says

Sep 09 2019

• By Derrick Gingery

FDAEntrance_1200x675 — The FDA may not be adequately communicating its rare disease flexibility policy to sponsors in official documents. • Source: File photo

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United States Drug Approval Standards Rare Diseases Drug Review Regulation FDA Review Pathway BioPharmaceutical

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