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FDA Releases Rare Disease Draft Guidance Document

The Food and Drug Administration has released a draft guidance document for navigating the unique challenges of developing treatments for rare diseases. It emphasizes the importance of understanding the natural history of a disease, creating study designs with clinically meaningful end points, establishing product safety and effectiveness, and ensuring product quality.

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NORD, rare disease,
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The Food and Drug Administration has released a draft guidance document for navigating the unique challenges of developing treatments for rare diseases. It emphasizes the importance of understanding the natural history of a disease, creating study designs with clinically meaningful end points, establishing product safety and effectiveness, and ensuring product quality.

The Food and Drug Administration has released a draft guidance document for navigating the unique challenges of developing treatments for rare diseases. It emphasizes the importance of understanding the natural history of a disease, creating study designs with clinically meaningful end points, establishing product safety and effectiveness, and ensuring product quality.

Publications
Publications
Article Type
Display Headline
FDA Releases Rare Disease Draft Guidance Document
Display Headline
FDA Releases Rare Disease Draft Guidance Document
Legacy Keywords
NORD, rare disease,
Legacy Keywords
NORD, rare disease,
Sections