FEDERAL · 21 CFR

§ 314.92-99 — Not Yet Available

21 C.F.R. § 314.92-99

21 C.F.R. § 314.92-99 is referenced in other legal documents but could not be loaded from the eCFR.

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Nearby Sections

15

§ 314.1

Scope of this part.

§ 314.2

§ 314.3

§ 314.50

Content and format of an NDA.

§ 314.52

Notice of certification of invalidity, unenforceability, or noninfringement of a patent.

§ 314.53

Submission of patent information.

§ 314.54

Procedure for submission of a 505(b)(2) application requiring investigations for approval of a new indication for, or other change from, a listed drug.

§ 314.55

Pediatric use information.

§ 314.56

Nonprescription drug product with an additional condition for nonprescription use (ACNU).

§ 314.60

Amendments to an unapproved NDA, supplement, or resubmission.

§ 314.65

Withdrawal by the applicant of an unapproved application.

§ 314.70

Supplements and other changes to an approved NDA.

§ 314.71

Procedures for submission of a supplement to an approved application.

§ 314.72

Change in ownership of an application.

§ 314.80

Postmarketing reporting of adverse drug experiences.