Bradley Merrill Thompson, Strategic Advisor with EBG Advisors and Member of the Firm in the Health Care & Life Sciences practice at Epstein Becker Green, was mentioned in BioWorld, in “FDA Combo Products Guidance Offers More Flexibility for Cross-Labeling,” by Mark McCarty. (Read the full version – subscription required.)
Following is an excerpt:
U.S. FDA regulation of combination products has always been complicated, and a new final guidance takes up the long-standing controversy over FDA review of these applications. The final guidance makes explicit the possibility that the individual components of a cross-labeled combination product will be reviewed separately, a concession that industry saw as critical to ensure that these applications can make it through the FDA gauntlet without undue delay. …
Representing the Combination Products Coalition (CPC), regulatory attorney Brad Thompson of Epstein Becker & Green P.C., noted in comments to the docket [that they had not finished our review of the guidance] …
