Patient Privacy

The names and addresses of patients should not be included in any reports submitted to the FDA. 21 C.F.R. ยงยง 310.305(e), 314.80(h), 314.81(c)(2), 314.98, 600.80(h). Instead, the applicant or licensed manufacturer should create a unique code number of less than eight characters for each report. Id. The applicant or licensed manufacturer must include the name of the person who reported the adverse product experience. Id. The applicant or licensed manufacturer also must maintain sufficient patient identification information to permit the FDA to identify the name and address of individual patients. Id.

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