Responsibilities for Assessment of In-Vitro Test for Oral DPs Administered Via Enteral Feeding Tube

This Manual of Policies and Procedures (MAPP) outlines the procedures for communication between the Office of Pharmaceutical Quality (OPQ) and the Office of Generic Drugs (OGD) as well as the Office of New Drugs (OND) when necessary, concerning the evaluation of in vitro testing methods for oral drug products administered through enteral feeding tubes. Additionally, this MAPP delineates collaboration efforts regarding the incorporation of enteral tube information into product labeling.