On July 26, 1995, CVM issued a Policy Letter announcing the Center's informal guidance document entitled "MASTER FILES -- Guidance for Industry for the Preparation and Submission of Veterinary Master Files." A master file (MF) is a voluntary submission to FDA that may be used to provide confidential, detailed information about the facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more veterinary drugs. Master files on file with CVM are generally referred to as veterinary master files (VMFs). This is to distinguish these files from those submitted to FDA's Center for Drug Evaluation and Research, which are referred to as drug master files (DMFs). The information in a VMF may be used to support an investigational new animal drug application (INADA), a new animal drug application (NADA), an abbreviated new animal drug application (ANADA), another VMF, an Export Application, or amendments or supplements to any of these.

A master file is not a substitute for an INADA, NADA, ANADA, or Export Application. It is not approved or disapproved. Instead, the submission is found acceptable or deficient in support of an INADA, NADA, ANADA, Export Application, or other master file.

The submission of a master file is not required by law or FDA regulation. Master files are generally created to allow a party other than the holder of the master file to reference material without disclosing to that party the contents of the file. When an applicant references its own material, the applicant should reference the material contained in its own INADA, NADA, or ANADA directly, rather than establishing a master file.

A master file is submitted solely at the discretion of the holder. All information submitted in a master file is considered confidential, and is reviewed only when the master file holder provides appropriate authorization permitting the FDA to refer to it on behalf of an applicant or sponsor.

This guidance document recognizes five distinct types of Veterinary Master Files (Types I - V) as well as public master files. It states that Type I VMFs are being eliminated, and that the Center will no longer accept new Type I VMFs or correspondence updating existing Type I VMFs. Also, the information in Type I VMFs currently on file can no longer be incorporated by reference into new applications, amendments, or supplements. Further definitions of the content of Type I -V VMFs and the mechanism by which Type I master files will be eliminated or recategorized are also included in the informal guidance document.

The informal guidance document also announces that a VMF will only be reviewed in conjunction with an application. Previously, CVM routinely reviewed submissions that were not necessarily linked to an application. The Center has concluded that the routine review and evaluation of VMFs not specifically referenced in applications may be a waste of resources, and will discontinue this practice.

Copies of the policy letter and the informal guidance document are available from the FDA Veterinarian. Comments and questions on the guidance document may be addressed to:

William G. Marnane
Center for Veterinary Medicine
Office of New Animal Drug Evaluation
HFV-143
7500 Standish Place
Rockville, MD 20855