Public Master Files (PMFs) Supporting Applications for Minor Use and Minor Species Drugs
Public Master Files are files that contain publicly available studies or other non-proprietary information. This information is intended to support drug approvals, often for minor use or minor species drugs. PMFs are established to provide access to this information and to enable public partners to share resources. Multiple sponsors can use these studies to support their approvals.
Each PMF includes public studies that may support a New Animal Drug Application (NADA) or supplemental NADA when used in conjunction with a pharmaceutical sponsor’s Chemistry, Manufacturing, and Controls (CMC) section, labeling section, and any other technical sections not complete in the PMF. Typically, a PMF includes the technical sections supporting effectiveness, target animal safety, human food safety, and environmental safety.
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 major use and major species.
Note: Studies described and referenced in Public Master Files or otherwise listed in these tables are intended to support, or have supported, new animal drug approvals. With the passage of time, or due to changes in requirements, some studies recorded here may no longer be sufficient to support a new approval.
Latest Public Master File Additions
- Public Master Files (PMFs) in development updated – information available for P005-042 (lasalocid sodium) and P005-662 (oxytetracycline dihydrate)
- Public Master Files (PMFs) in development updated – target animal safety information available for P005-644 (fenbendazole)
- Public Master Files (PMFs) in development updated - information available for P006-060 (eugenol) and P006-082 (Progesterone-impregnated controlled intravaginal drug release (CIDR) device)
- Public Master Files (PMFs) in development updated - information available for P005-165 (erythromycin thiocyanate) and P006-060 (eugenol)
- Public Master Files (PMFs) in development updated - information available for P005-644 (fenbendazole), P006-060 (eugenol), and P006-061 (emamectin benzoate)
- Public Master Files (PMFs) in development updated - Technical section complete letters available for P005-042 (lasalocid), P005-590 (copper sulfate), and P005-639 (hydrogen peroxide)
Helping Agriculture's Helpful Honey Bees
FDA Announces the Availability of Safety and Effectiveness Data to Support a New Animal Drug Application for Aquaculture[ARCHIVED]
FDA Issues an Announcement of the Availability of Safety and Effectiveness Data to Support a Minor Species New Animal Drug Application[ARCHIVED]
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