Annual industry ranking and forecast
Policy & Regulation
Big-picture policy developments – a deeper look at Operation Warp Speed in the US, exploration of the FDA’s new ‘D’ meetings and a review of changes for improved access to hearing aid technologies.
Operation Warp Speed’s seal was a combination of ’70s design, au courant clip art, and 18th Century militarism, but just like the oddly assembled organization that it represented, the thing worked.
From innovation to legislation, the US audiology market is being shaped by cutting-edge technology from device makers and legislation from the Biden administration to get more hearing aids to those that need them.
New ‘Type D’ meetings will be added as part of PDUFA VII, one of a spate of changes under the next version of the user fee program that will begin in October 2022.
The EU research-based pharma industry is exploring partnerships to develop an app that would extract data from the new Clinical Trial Information System and convert it into lay format to guide patients interested in participating in studies.
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