The nascent National Evaluation System for health Technology was a consistent topic of debate between US FDA and industry during the past year's user-fee negotiations, but eventually made it into a tentative deal that will be presented to Congress for approval. At a Nov. 2 FDA public meeting on the user-fee deal, patient groups said they appreciated FDA and industry supporting the initiative, which initially got pushback from device-makers due to skepticism on how it would benefit companies in the pre-market setting.
FDA, industry, research advocacy and patient advocacy groups discussed how they worked to put a new MDUFA IV deal together...
