Federal (United States) · Regulations
Subpart B
6 sections
6 sections
- 21 C.F.R. § 314.54Procedure for submission of a 505(b)(2) application requiring investigations for approval of a new indication for, or other change from, a listed drug.
- 21 C.F.R. § 314.56Nonprescription drug product with an additional condition for nonprescription use (ACNU).
- 21 C.F.R. § 314.60Amendments to an unapproved NDA, supplement, or resubmission.
- 21 C.F.R. § 314.65Withdrawal by the applicant of an unapproved application.
- 21 C.F.R. § 314.70Supplements and other changes to an approved NDA.
- 21 C.F.R. § 314.71Procedures for submission of a supplement to an approved application.