StacksVerified U.S. regulatory reference

21 CFR §314.98

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (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.
  2. (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.