FDA Issues New MAPP on How it Develops MAPPs

The FDA released a new Manual of Policies and Procedures (MAPP) last week explaining how it develops and issues MAPPs within the Center for Drug Evaluation and Research — and announcing a plan to retire outdated manuals.

The manuals, which function as directives on policies and procedures for agency staff, remain in effect until revised, recertified or cancelled, the agency noted.

To avoid any confusion caused by outdated MAPPs, starting in January 2023, the FDA plans to move outdated MAPPs that are older than five years to an internal website. The agency’s offices will receive a three-month notice before any MAPP is removed but they may request an extension on a case-by-case basis, the agency said.