CDER Updates Staff Guidance on Pharmacologic Classes for Prescribing Information

The FDA released an updated version of its 2013 Manual of Policies and Procedures (MAPP) outlining CDER’s procedures for determining pharmacologic classes for use in prescribing information for drugs.

The agency says sponsors of NDAs should consult clinical reviewers for all proposed terms to ensure they’re clinically meaningful and should consult other CDER review staff where necessary.

For all NDAs containing already approved active moieties, CDER’s pharmacology/toxicology reviewer must check the established pharmacologic class text phrases proposed for the product’s “indications and usage” section.