Public Master Files (PMFs) in development

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The dates in the following table represent work to support the approval of new animal drug applications (NADAs) that has been done by public entities. The dates in columns headed: Target Animal Safety, Effectiveness, and Environmental Impact represent the completion of all of the work determined to be necessary to support that technical section of an NADA on the date appearing in the table. Dates in the column headed Human Food Safety represent completion of a significant portion of that technical section of an NADA. These portions are represented by the following footnotes in the table:

¹-microbial food safety - antimicrobial resistance
²-microbial food safety - impact on human intestinal flora
³-toxicology
⁴-residue chemistry

Even when dates are present in all columns it does not represent a complete approval package. Technical sections completed in a PMF will typically not include the Chemistry, Manufacturing, and Controls (CMC) section, the toxicology portion of the Human Food Safety section or the labeling section. These technical sections are typically in a proprietary file belonging to a pharmaceutical sponsor. Sponsors for applications for food producing animals need to own the toxicology data or have a right of reference to use such data owned by another sponsor to complete the human food safety technical section.

The absence of a date in a column does not necessarily mean that no work has been done by public entities, only that sufficient work has not been done to warrant issuance of a Technical Section Complete (TSC) letter or to complete a significant portion of the Human Food safety section of an NADA.

Note: While the conclusions that FDA reached in the review of studies submitted to us and reflected in the letters represented in the table are generally sufficient to support those portions of an application, the validity of these determinations may be affected by advancing scientific knowledge, changing requirements, or significant passages of time.