21 CFR 314.98 : 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) — Postmarketing reports.

4 Aug 2016

(a) Each applicant having an approved abbreviated new drug application under § 314.94 that is effective must comply with the requirements of § 314.80 regarding the reporting and recordkeeping of adverse drug experiences.

(b) Each applicant must make the reports required under § 314.81 and section 505(k) of the Federal Food, Drug, and Cosmetic Act for each of its approved abbreviated applications.

21 CFR 314.98
[79 FR 33089, June 10, 2014]