Orphan drug designation 1 article

Orphan Drug designation is a regulatory status intended to encourage development of therapies for rare diseases or conditions that meet statutory criteria. In the United States, the designation can provide development incentives such as fee-related benefits, tax-related support where applicable and potential market exclusivity after approval for the designated use. It is distinct from FDA approval: a product may receive orphan designation during development but must still demonstrate the evidence required for marketing authorization.