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 In this section:

                Development & Approval Process

Development & Approval Process

                        Environmental Impact Considerations
          Food Additive Petitions for Animal Food
          Public Master Files (PMFs) Supporting Applications for Major Use and Major Species Drugs
          Veterinary Feed Directive (VFD)
          Veterinary Master Files


                        Abbreviated New Animal Drug Applications
          Modernizing FDA’s and EPA’s Approach to Oversight of Products for Animals Regulated as Pesticides or New Animal Drugs
          Aquaculture
          Biotechnology Products at CVM: Animals and Animal Food
          Electronic Submissions
          Minor Use/Minor Species
          New Animal Drug Applications
          User Fees Home
          Animal & Veterinary
          Development & Approval Process
          Public Master Files (PMFs) Supporting Applications for Major Use and Major Species DrugsDevelopment & Approval Process Public Master Files (PMFs) Supporting Applications for Major Use and Major Species Drugs
  
  	
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    PrintPublic 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.*

Public Master Files (PMFs) in Development

                                                                                  Content current as of:
      01/26/2024Development & Approval Process

          
                        Environmental Impact Considerations
          Food Additive Petitions for Animal Food
          Public Master Files (PMFs) Supporting Applications for Major Use and Major Species Drugs
          Veterinary Feed Directive (VFD)
          Veterinary Master Files


                        Abbreviated New Animal Drug Applications
          Modernizing FDA’s and EPA’s Approach to Oversight for Animal Products
          Aquaculture
          Biotechnology Products at CVM: Animals and Animal Food
          Electronic Submissions
          Minor Use/Minor Species
          New Animal Drug Applications
          User Fees
 
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