Oncologic Drugs Advisory Committee

Oncologic Drugs Advisory Committee

February 8, 2011, from 8 a.m. to 5 p.m.

Agenda: The committee will hear updates on new drug applications (NDAs) and biologics license applications (BLAs) approved under 21 CFR 314.500 and 601.40 (subpart H and subpart E, respectively, accelerated approval regulations) prior to January 1, 2009. These updates will provide information related to the status of phase IV clinical studies and to difficulties associated with completion of phase IV commitments. Phase IV studies are post marketing studies to confirm clinical benefit of a drug after it receives accelerated approval.