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U.S. Code of Federal Regulations

Regulations most recently checked for updates: Aug 28, 2025

All TitlesTitle 21Chapter IPart 99Subpart D - Subpart D—FDA Action on Submissions, Requests, and Applications
§ 99.301 - Agency action on a submission.
§ 99.303 - Extension of time for completing planned studies.
§ 99.305 - Exemption from the requirement to file a supplemental application.
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