ARTICLE SUMMARY:
FDA provides more details on the draft MDUFA VI agreement. Excerpted from Pathways Picks July 15: America First" Fees, Remote Monitoring Restrictions, Aussie Advertising Code, and More.
FDA confirmed July 10 it is “implementing fee structure changes to ensure foreign firms are contributing an appropriate share of user fee revenue given the additional resources required to oversee foreign firms marketing devices in the US.” Earlier last week, the agency posted its draft commitment letter, which Market Pathways reported on, laying review timelines and other program priorities for the next, MDUFA VI user fee cycle. A fact sheet posted July 10 provides more, though still limited, details about the structure of fees companies will pay under MDUFA VI, including affirming the “America First” attributes of the deal. The document suggests that only small businesses “with US tax returns” can qualify for user fee discounts and expanded waivers under the MDUFA VI agreement. And, generally, it notes, “US-based firms, among others, will see total fees coming down.” The fact sheet doesn’t explain exactly how fees will be calculated differently for US vs. foreign firms.