FDA publishes manual on complex product classification for generic development

The US Food and Drug Administration (FDA) recently published a manual of policies and procedures (MAPP) outlining how the Office of Generic Drugs (OGD) will classify which new drugs and drug-device combination products are complex products for generic drug development purposes. The manual  provides definitions and examples of complex drugs and drug-device combination products, as well as the responsibilities and procedures for the OGD’s Complex Drug Working Group. The MAPP is part of FDA’s larger Drug Competition Action Plan, which has improving the efficiency of generic drug development as one of its core aims.  A link to the MAPP can be found here MAPP Policy and Procedure Template (fda.gov)