MDUFA IV: Industry Focuses On Premarket Review Consistency; FDA Pushes Postmarket, IT Funding

Key issues are starting to emerge as FDA and the medical device industry gear up to present their user fee proposals next Wednesday (Nov. 18) at a closed-door meeting that is expected to jump-start preliminary discussions on reauthorization of the user fee agreement set to expire in 2017. Sources said the negotiations will likely focus more around processes, as opposed to shorter approval times, including ways to improve consistency in the premarket review phase and create a more streamlined approach...