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21 CFR 3.10

§ 3.10 Stay of review time.

United States · 21 CFR — Food and Drugs · Status: effective

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21 CFR 3.10, § 3.10 Stay of review time, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/83002
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Full text

Any filing with or review by the product jurisdiction officer stays the review clock or other established time periods for agency action for an application for marketing approval or required investigational notice during the pendency of the review by the product jurisdiction officer.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.