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FDA seeks balance between flexibility and adequacy in proposed drug risk standards for broadcast DTC ads

This article was originally published in Scrip

Executive Summary

The US FDA is proposing standards for determining whether side-effect related statements in direct-to-consumer (DTC) TV and radio advertisements are presented in a "clear, conspicuous and neutral manner". The agency was instructed to do so by a provision of the FDA Amendments Act of 2007. It says that its proposed guidelines provide "flexibility" for drug sponsors to be creative in how they meet the four criteria set forth in a newly proposed rule, and it also seeks comments from industry.




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