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FDA Used Invokana Review To Reflect On Diabetes CV Risk Policy

 
• By Bridget Silverman

Agency officials viewed the review of canagliflozin – the first program started after the 2008 outcomes trial requirement – as a chance to look at lessons learned since the policy went into effect.

As the first drug approved with full implementation of FDA’s cardiovascular risk requirements for diabetes drugs, the review of Johnson & Johnson’s Invokana (canagliflozin) provided an opportunity for FDA to reflect on how diabetes programs that incorporate risk assessment from the outset should be conducted, rather than parsing data from retrofitted or inadequate trial programs.

FDA’s 2008 guidance requiring cardiovascular risk assessment for anti-diabetics was one of the most seismic regulatory events of the past...

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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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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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US FDA’s Rising First-Cycle Complete Response Rate Draws Congress’ Attention

 
• By Sue Sutter

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‘Clean Sweep’ Of US CDC Vaccine Committee Puts Kennedy In Driver’s Seat

 
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Infographic: Leqembi – A Geographical Comparison

 
• By Anabel Costa-Ferreira

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