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FDA announces Public Master Files - Publicly available studies or other non-proprietary information supporting drug approvals

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  • FDA announces Public Master Files - Publicly available studies or other non-proprietary information supporting drug approvals

    FDA announces Public Master Files - Publicly available studies or other non-proprietary information supporting drug approvals

    http://www.fda.gov/AnimalVeterinary/.../ucm279384.htm

    Public Master Files (PMFs)

    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 sponsorís 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 sponsorís own file. Such data are not part of the PMF.
    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.
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