Title 21

PART 99 SUBPART D

Subpart D - FDA Action on Submissions, Requests, and Applications

• 21 U.S.C. 321, 331, 351, 352, 355, 360, 360c, 360e, 360aa-360aaa-6, 371, and 374; 42 U.S.C. 262.
• 63 FR 64581, Nov. 20, 1998, unless otherwise noted.

21:1.0.1.1.34.4.63.1	SECTION 99.301	99.301 Agency action on a submission.
21:1.0.1.1.34.4.63.2	SECTION 99.303	99.303 Extension of time for completing planned studies.
21:1.0.1.1.34.4.63.3	SECTION 99.305	99.305 Exemption from the requirement to file a supplemental application.

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