CDER Updates Policies on Expedited Review of Prior Approval Supplements

CDER released a revised Manual of Policies and Procedures on expedited reviews of prior approval supplements for new drug and biologics license applications that involve chemistry, manufacturing and controls changes.

Expedited review requests will be considered by CDER’s Office of Pharmaceutical Quality on a case-by-case basis, but applications should address a drug shortage or a public health emergency or qualify for a special review program such as the president’s emergency plan for AIDS relief, according to the MAPP.

For an expedited review, the office will attempt to complete the review before the drug’s PDUFA goal date.