Natural History

FDA Guidance–Rare Diseases: Natural History Studies for Drug Development

Mar 27, 2019 | FDA, Natural History, News, Rare Diseases, Regulations, Regulatory Affairs, Regulatory Findings

The Food and Drug Administration (FDA) has released a draft guidance titled “Rare Diseases: Natural History Studies for Drug Development” with the intention to inform both the design and execution of natural history studies to support the development of safe and...

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FDA Guidance–Rare Diseases: Natural History Studies for Drug Development

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