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FDA Action on Submissions, Requests, and Applications | Midpage
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Code of Federal Regulations
Title 21
Chapter I
Subchapter A
Part 99
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.