Sunset
FDA can issue a Written Request for a drug (active moiety) after January 1, 2002, only if:
an application for the drug is submitted on or before January 1, 2002; and
the drug was in commercial distribution on November 21, 1997; and
the drug is on the List on January 1, 2002; and
FDA finds that there is
- continuing need for information and
- the drug may provide health benefits