MAPP on Need, Review of New REMS

CDER has issued a Manual of Policies and Procedures (MAPP) on the procedures the Center will use to determine whether a risk evaluation and mitigation strategy (REMS) for a prescription drug product marketed under an NDA or BLA is needed to ensure that the drug’s benefits outweigh its risks. The document says the MAPP also describes the procedure for reviewing a proposed REMS submission developed by an NDA or BLA applicant to determine if it is acceptable.

The MAPP applies to a new REMS being developed at either the preapproval or postapproval stage, it says. It does not pertain to a shared system REMS developed by multiple applicants for NDAs, ANDAs, and BLAs, and also does not apply to modifications to an approved REMS.

The document says the CDER Office of Surveillance and Epidemiology and Office of New Drugs will jointly determine the need for and the components of the REMS for a drug approved under an NDA or BLA.