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What is a premarket review timeliness dispute?

April 26, 2017combination product dispute fda formal disputes guidance premarket premarket review review timeliness

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What is a premarket review timeliness dispute?

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For the purpose of this guidance document, a timeliness dispute arises when FDA does not review and act on an applicant’s premarket submission within the applicable time frame, and the applicant presents the issue to OCP for resolution. For example, if an applicable time frame states that a particular action is to be taken within 90 days, and the action is not taken by that time, the sponsor or applicant may present the issue to OCP for resolution.