Rosen Comments on Proposed New FDA Guidance on Drug-Device Combination Products

Partner David Rosen is quoted in a Health Care on Bloomberg Law article, “FDA Seeks to Speed Approvals of Generic Drug-Device Combos,” about proposed new FDA guidance that will make it easier for generic companies to get drug-device combination products approved.

Rosen said the proposed guidance, which will allow a generic product to have certain labeling differences from the branded product if the labeling changes come from permitted design differences, could present safety issues.

“We have to make sure that there’s no potential for patient confusion, as well as caregiver confusion” if there are differences in the labeling, he said. “What we don’t want is something that is less safe or less effective than what is currently out there.”