Annual Reports

In addition to the periodic safety reports that applicants submit to the FDA, annual reports also are required for drugs that include other safety information. Annual reports include a variety of information including distribution data and manufacturing changes, but they also include safety information in the form of copies of unpublished reports of new clinical and preclinical findings. 21 C.F.R. §§ 314.81(b)(2).


Applicants and licensed manufacturers are not required to report adverse product experience information that has already been reported to the FDA. Thus, no report should contain adverse product experiences that occurred in clinical trials if those experiences were previously submitted as part of an approved application. 21 C.F.R. §§ 314.80(g), 314.98, 600.80(g). Similarly, an applicant or licensed manufacturer is not required to file a report if the FDA was the source of the adverse product experience information and no additional information was uncovered during the "follow-up" investigation. 21 C.F.R. §§ 310.305(c)(5), 314.80(b), 314.98, 600.80(b).

The reporting requirements apply to all entities identified on the product's label as manufacturers, packers, or distributors. 21 C.F.R. §§ 310.305(c)(1)(i), 314.80(c)(1)(iii), 314.98, 600.80(c)(1)(iii). In order to avoid duplication in reporting, however, these entities may submit any adverse product experience information to the applicant or licensed manufacturer for inclusion in the applicant or licensed manufacturer's 15-day Alert report. 21 C.F.R. §§ 310.305(c)(3), 314.80(c)(1)(iii), 314.98,

600.80(c)(1)(iii). This submission must occur within five calendar days of the entities' receipt of the information. Id. If the entity elects this method, it must keep a record that includes a copy of each adverse product experience report, the date that it received the report, the date that the report was submitted to the applicant or licensed manufacturer, and the name and address of the applicant or licensed manufacturer. Id.

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