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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: What The Logo Can Tell Us About Successful Pandemic Preparedness

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.

Listen Up! Big Things Happening In The World Of Audiology

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.

When It Comes To Sponsor Meetings, FDA Is Getting A ‘D’

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.

New EU Clinical Trials System Could Support Patient Recruitment

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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The Lasting Impact Of The Pandemic On Pharmacovigilance 

Annette Williams, vice president and global head of lifecycle safety at IQVIA

Despite the critical importance of pharmacovigilance (PV) activities, two years ago it was a concept with which most people outside the life sciences space were largely unfamiliar. Since the onset of the COVID-19 pandemic, however, this has changed immensely.

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Outlook 2022 e-Book

Outlook 2022 cover

Download a PDF copy of the Outlook 2022 collection, including Scrip 100 league tables.