Master Files: Guidance for Industry for the Preparation and Submission of211 Veterinary Master Files

摘要

This document is intended to provide guidance for the preparation and submission211u001eof master files to the Center for Veterinary Medicine. This document discusses 211u001ethe types of master files, information needed, submission format, procedures 211u001egoverning the review of master files, and obligations of the master file holder. 211u001eA master file is a voluntary submission to the Food and Drug Administration that 211u001emay be used to provide confidential, detailed information about facilities, 211u001eprocesses, or articles used in the manufacturing, processing, packaging, and 211u001estoring of one or more veterinary drugs.