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# Establishing Pharmacologic Class MAPP
- URL: https://www.fdaweb.com/establishing-pharmacologic-class-mapp/
- Published: 2018-07-25T12:00:00.000Z
- Updated: 2026-09-15T00:21:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141959

CDER has issued a Manual of Policies and Procedures (MAPP) outlining the process CDER review staff follows when **(1)** selecting or creating an established pharmacologic class text phrase that will be associated with an approved indication and included under the Indications and Usage section of labeling; and **(2)** assigning clinically meaningful and scientifically valid pharmacologic concepts to each active moiety for use in indexing the labeling. The [document](https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM361380.pdf?ref=fdaweb.com) says the process involves Office of New Drug (OND) pharmacology/toxicology reviewers. The OND associate director for pharmacology and toxicology or other designated staff, other CDER review staff as appropriate, and the Office of the Commissioner/Office of the Chief Scientist health and regulatory data standards staff.

The MAPP defines a pharmacologic class as a group of active moieties that share scientifically documented properties. An established pharmacologic class is a pharmacologic class associated with an approved indication of an active moiety that FDA has determined to be scientifically valid and clinically meaningful according to specific definitions.