Orphan drug designation is a special status granted by the FDA to drugs intended for the treatment of rare diseases or conditions affecting fewer than 200,000 people in the United States. This designation encourages the development of treatments for conditions that might otherwise be overlooked due to a lack of financial incentive. By providing benefits like tax credits and extended exclusivity, orphan drug designation plays a crucial role in both the drug approval process and strategies to maintain market exclusivity for developers.
congrats on reading the definition of Orphan Drug Designation. now let's actually learn it.