US FDA’s Shuren: Device Center Will Roll Out New Strategic Priorities In 2022
Center for Devices and Radiological Health director Jeff Shuren said on 22 July that the center is incorporating lessons learned from the COVID-19 pandemic and its ongoing user-fee negotiations with industry into its upcoming set of strategic goals.
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The US agency says it has either met or exceeded all its 2018-2020 strategic priorities, including simplifying core processes in its product review pathways.
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.
The new collaborative community from MedTech Color – the 11th that the US FDA has formally recognized – will push for better representation for people of color in clinical studies and other product development activities.