MDUFA IV Makeover For US FDA Guidances
The US agency detailed new review performance goals and user-fee policies to mark the start of a new fiscal year and five-year user-fee program.
You may also be interested in...
As part of its MDUFA IV commitments, the US agency will launch a pilot program that will streamline how sponsors can track their premarket applications online.
The Breakthrough Devices Program is the established Expedited Access Pathway with some statutory updates, including the addition of 510(k)-pathway devices. But FDA also uses the congressionally-mandated draft guidelines to outline some new features in the program that are not in the statute, including a process for "breakthrough device sprint discussions."
AdvaMed CEO Scott Whitaker says Alex Azar, who is reportedly the top candidate to be nominee for US Health and Human Services secretary, would be ideal for the job with his extensive experience at the department.