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FDA Comments on Recently Released Rare Disease Guidance for Industry

Jonathan Goldsmith, M.D., F.A.C.P., FDA’s Associate Director, Rare Diseases Program, Center for Drug Evaluation and Research, comments on the recently released draft guidance for industry on rare disease drug development. Given the complexity and challenges of developing and bringing to market new FDA-approved drugs to treat rare diseases, we're excited to see this topic garnering more support.

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#fda #raredisease #guidance #drugdevelopment #orphandrug

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