US FDA’s Shuren Promises MDUFA Update ‘Relatively Soon’
FDA device center director Jeff Shuren told Medtech Insight he anticipates MDUFA V negotiation minutes that have not been published in four months will be available imminently.
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Booz Allen Hamilton’s report found that for the most part the agency has fulfilled its user fee obligations – but one major shortcoming is an unpublished digital health guidance.
MDUFA V: Industry, FDA Tangle Over TAP Program, Agency Finances, Reinstatement Of Fifth-Year Offset Funds
In newly published meeting minutes, industry and the US FDA continued to clash over a proposal to create a new pre-submission advisory program and what to do with carryover user-fee funds.
Regulators say that despite millions of HIV viral load monitoring tests on the market over the past 25 years, there has only been on class II recall for the products, which warrants easing their path to market.