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Attorney: FDA draft re-do of Part 3 eases agency's legal burden

By Mark McCarty
Regulatory Editor

Thursday, May 17, 2018

The FDA has floated a rewrite of the so-called Part 3 appeals process for combination product designation to address widespread confusion about the process, but regulatory attorney Brad Thompson, of Epstein Becker Green, said the proposed changes would effectively reduce the rule to a guidance, which benefits the FDA in that "guidance can't be cited as a binding requirement against FDA" in legal proceedings.

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