§314.98. Postmarketing reports.
21 C.F.R. § 314.98
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.
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.
Notes, amendments, and revision history
Amendments
[79 FR 33089, June 10, 2014]
Source
Source: 57 FR 17983, Apr. 28, 1992, unless otherwise noted.
Authority
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 355a, 355f, 356, 356a, 356b, 356c, 356e, 360cc, 360ddd, 360ddd-1, 371, 374, 379e, 379k-1.
Source
Source: 50 FR 7493, Feb. 22, 1985, unless otherwise noted.
Amendments
[79 FR 33089, June 10, 2014]