Bradley Merrill Thompson, Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in BioWorld, in “Attorney: FDA Draft Re-Do of Part 3 Eases Agency’s Legal Burden,” by Mark McCarty. (Read the full version – subscription required.)
Following is an excerpt:
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.
