Pharmacovigilance & Drug Safety

Orphan drugs

The FDA has authority to grant orphan-drug designation to a drug or biological product to prevent, diagnose or treat a rare disease or condition. Orphan drug designation qualifies sponsors for incentives including: Tax credits for qualified clinical trials. What is the Orphan Drug Act? The Orphan Drug Act is a law passed by Congress in 1983 that incentivizes the development of drugs to treat rare diseases. Companies and other drug developers can request orphan drug designation and FDA will grant such designation if the drug meets specific criteria.