In this week’s roundup: MDUFA V takes effect—what to expect in the short term. Europe’s health division reorganizes, including more focused leadership for medical products. UK news from MHRA and NICE. Harmonization updates: FDA-Canada pilot, IMDRF advances, Philippines guide. And more from India and the US.
A New MDUFA in Town
A transition at FDA:
The US government’s fiscal year 2023 started October 1. And while there likely weren’t any new year’s parties over the weekend, the date marks an important regulatory milestone for medtech. After a year-plus of FDA-industry negotiations and a very last minute congressional approval last week, the new five-year MDUFA V user fee program has officially taken effect. For a detailed summary of the key elements of the program, check out our MDUFA V infographic. And here are a few near-term things to watch out for as FY 2023 gets going: