Sunset
Studies submitted on or after January 1, 2002, can earn pediatric exclusivity if:
- the studies are submitted in response to a Written Request issued on or before January 1, 2002, and
- the Written Request is for a drug (active moiety) for which an application was submitted on or before January 1, 2002.
FDA cannot issue a Written Request for a drug (active moiety) after January 1, 2002, if the first application for the drug is submitted after January 1, 2002.