Safety Labeling Changes MAPP

A CDER Manual of Policies and Procedures gives the policies and procedures for staff in the Office of New Drugs, Office of Generic Drugs, and other CDER offices when implementing the law on requirements for safety labeling changes for approved drugs under the FDA Amendments Act of 2007 (FDAAA). The MAPP says the agency is authorized to require and, if necessary, order application holders of certain approved drugs to make safety labeling changes based on new safety information that becomes available after the drug’s approval. The law gives timeframes for application holders to submit and for agency staff to review such changes, and gives CDER enforcement tools in instances of noncompliance, it says.

Generally, according to the MAPP, CDER will require such FDAAA safety labeling changes when the Center determines that new safety information about a drug should be included in the labeling, in accordance with established FDA guidance on such labeling changes.