(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.

[79 FR 33089, June 10, 2014]