2021 Forecast Includes Rise In FDA Enforcement Actions

The Biden administration may take a heavier hand with manufacturers than we saw in recent years, attorneys say.

Continuing fallout from the COVID-19 pandemic, user-fee negotiations and potential legislative action are among the device regulatory areas two attorneys from the law firm Paul Hastings expect to be paying close attention to during the coming year.

During a 28 January webinar, the attorneys said to watch any moves on remote inspections from the US Food and...

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Broad participation by EU member states in a new pilot to test a unified procedure for evaluating applications for combined drug and IVD studies shows they recognize its value, says Monique Al, vice-chair of the Clinical Trials Coordination Group.

EU Life Sciences Strategy Must Address ‘Regulatory Lasagna’

 

MedTech Europe is ready to become involved and shape Europe’s Life Sciences Strategy and help drive regulatory simplification from the top to make the EU “the world’s most attractive place for life sciences by 2030.”

Questions Over UK Prevention Agenda Within NHS 10-Year Plan

 
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The UK government’s blueprint to deliver an NHS "fit for the future" was released on July 3.