Reporting Adverse Product Experiences From Marketed Products

The regulations require two specific types of postmarketing reports for post-marketing adverse product experiences: 15-day Alert reports and periodic reports.

All adverse product experience reports for both drugs and biological products (unless treated differently as discussed above) should include a completed FDA Form 3500A for each individual patient or publication, unless the adverse product experience is foreign, in which case either a Form 3500A or a CIOMS I is acceptable. 21 C.F.R. ยงยง 314.80(f), 600.80(f). If the product is a vaccine, a VAERS form should be used. Applicants or licensed manufacturers may use computer-generated forms or use an alternative format, such as a computer-generated tape or tabular listing, if the alternative format contains the same content as Form 3500A and the appropriate FDA department agrees to the alternate format in advance. Id.

The FDA has proposed a regulation requiring the reporting of adverse product experiences in electronic form, but has not taken final action on the matter. 63 Fed. Reg. 59,746 (1998).

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