Public Master Files (PMFs) Supporting Applications for Major Use and Major Species Drugs
Public Master Files are files that contain publicly available studies or other non-proprietary information intended to support drug approvals. Drug sponsors can use the information in PMFs to support their approvals.
Each PMF includes information that may support a New Animal Drug Application (NADA) or supplemental NADA when used in conjunction with a drug sponsor’s Chemistry, Manufacturing, and Controls (CMC) section, labeling section, and any other technical sections not complete with the information in the PMF.
The proprietary data submitted to complete an NADA package remains confidential in the sponsor’s own file. Such data are not part of the PMF.
PMFs are also used to support the approval of drugs for minor use and minor species.
Note: While information in a PMF is generally expected to support or complete portions of an NADA, completeness will be determined when a sponsor references the PMF for CVM review under their Investigational New Animal Drug (INAD) file or NADA. The completeness of the information may also be affected by advancing scientific knowledge, changing requirements, or significant passages of time.