Platform Technology Designation Program; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Platform Technology Designation Program for Drug Development." The purpose of this draft guidance is to provide details about the implementation of the Platform Technology Designation Program established by the PREVENT Pandemics Act. This draft guidance outlines eligibility factors for receiving a platform technology designation, potential benefits of receiving a designation, how to leverage data from designated platform technologies, how to discuss the planned designation request as part of a milestone meeting, the recommended content of a designation request submission, and the review timelines for a designation request. This draft guidance, when finalized, will represent the current thinking of FDA.
Abstract as published in the Federal Register.
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