FDA Issues New Guidance for Rare Diseases
Rare Diseases: Natural History Studies for Drug Development Guidance
On March 22nd, the FDA issued the draft guidance, Rare Diseases: Natural History Studies for Drug Development Guidance for Industry. A natural history study describes the course of a rare disease over time, identifying demographic, genetic, environmental, and other variables that correlate with its development and outcomes. Natural history studies can be prospective or retrospective. Read more