Speaking Of Medtech, Ep. 5: MDUFA V User-Fee Negotiations
Citeline Podcasts
English - December 07, 2021 20:37 - 26 minutes - 18.7 MB - ★★★★★ - 24 ratingsBusiness News Business News Homepage Download Apple Podcasts Google Podcasts Overcast Castro Pocket Casts RSS feed
In this episode of Speaking Of Medtech we discuss the Medical Device User Fee Amendments, or MDUFA, the negotiations for which come around every five years. The MDUFA V talks between industry and the US FDA appear with the inevitability of an unloved season – it seems no one is ever terribly excited to engage in the user-fee process. Here, we break things down.
Medtech Insight articles addressing topics discussed in this episode:
FDA Official: Uptick In PMA, 510(k) Applications Calls For More User Fee Dollars
https://medtech.pharmaintelligence.informa.com/MT144795/FDA-Official-Uptick-In-PMA-510k-Applications-Calls-For-More-User-Fee-Dollars
MDUFA IV Report: US FDA Needs To Publish Digital Health Guidance
https://medtech.pharmaintelligence.informa.com/MT144544/MDUFA-IV-Report-US-FDA-Needs-To-Publish-Digital-Health-Guidance
US FDA’s Shuren Promises MDUFA Update ‘Relatively Soon’
https://medtech.pharmaintelligence.informa.com/MT144512/US-FDAs-Shuren-Promises-MDUFA-Update-Relatively-Soon
MDUFA V: Industry, FDA Tangle Over TAP Program, Agency Finances, Reinstatement Of Fifth-Year Offset Funds
https://medtech.pharmaintelligence.informa.com/MT144183/MDUFA-V-Industry-FDA-Tangle-Over-TAP-Program-Agency-Finances-Reinstatement-Of-FifthYear-Offset-Funds
MDUFA V: FDA And Industry Still At Odds Over Carryover Funds, Vacancies, Meeting Commitments
https://medtech.pharmaintelligence.informa.com/MT143859/MDUFA-V-FDA-And-Industry-Still-At-Odds-Over-Carryover-Funds-Vacancies-Meeting-Commitments