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Tainted Supplement Recalls Prompt Call For Tighter Regulations – Letter

 
• By Lisa Gillespie

A research letter says that tainted supplements accounted for more than half of class I recalls from 2004-2012, and the researchers argue for stricter regulation. Industry points to a steep drop-off after 2010, and call for stronger enforcement of existing regulations.

The authors of a research letter showing adulterated supplements accounted for 51% of class I recalls over a nine-year period say the evidence supports stricter regulation for dietary supplements.

Supplement advocates, however, point out the data show a drop-off in such recalls since FDA announced it was targeting products...

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EMA Touts Faster Global Post-Approval Changes Via Regulatory Reliance

 
• By Eliza Slawther

The European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.

Novavax’s COVID-19 Vaccine Label Narrowed After Political Officials Intervened

 
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The label that Novavax's COVID-19 vaccine was slated to receive before political officials held up the approval was broader than was granted 16 May.

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Updated: Makary Backs New Novavax COVID-19 Trial, Political Officials Take Over Product Review

 
• By Sarah Karlin-Smith

In an unusual move, Tracy Beth Høeg, a special assistant to FDA Commissioner Martin Makary, is leading the continued negotiations on Novavax’s delayed COVID-19 vaccine approval.

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