21 CFR 314.97 : Food And Drugs (§ 1.1 To Parts 1403-1499) — (Subpart A To Parts 370-499) — Food And Drug Administration, Department Of Health And Human Services (Continued) (Subpart A To Parts 370-499) — Drugs For Human Use (Subpart A To Parts 370-499) — Applications For Fda Approval To Market A New Drug (§ 314.1 To § 314.650) — Abbreviated Applications (§ 314.92 To § 314.99) — Supplements and other changes to an approved abbreviated application.

4 Aug 2016

The applicant shall comply with the requirements of §§ 314.70 and 314.71 regarding the submission of supplemental applications and other changes to an approved abbreviated application.

21 CFR 314.97