FDA Orphan Drug Designation

The FDA Orphan Drug Designation is a special status given to medications aimed at treating rare diseases affecting fewer than 200,000 people in the U.S. It encourages pharmaceutical companies to develop these drugs by offering benefits such as tax credits, grant funding, exclusive marketing rights for a period, and assistance with the approval process. This designation helps ensure that patients with rare conditions have access to necessary treatments by making drug development more financially feasible for companies.