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This article was originally published in The Tan Sheet

Executive Summary

FDA decides against revising the 3500 (voluntary) and 3500A (mandatory) adverse event reporting forms, the agency announces in the Sept. 20 Federal Register. FDA received 21 comments in response to proposed changes announced in November. While comments on Form 3500 revisions were mainly favorable, comments on 3500A expressed concerns about financial burden on pharmaceutical and medical device industries in reprogramming computer systems. FDA says its decision "reflects both concerns about the financial burden that would be placed on FDA if the voluntary form underwent revision and the availability of other avenues by which use of the voluntary and mandatory forms can be optimized, namely appropriate revision of documents related to their completion." Updated instructions for completing 3500, including solicitation of dietary supplement information, were posted on the MedWatch home page in December, and a guidance for completing 3500A is being drafted

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