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Ruling Against Cigarette Warnings Could Impact Other FDA Labeling

 
• By Brenda Sandburg and Malcolm Spicer

A judge’s opinion that requiring graphic images on cigarette packages unconstitutionally compels speech could affect FDA’s qualifications for supplement health claims and its off-label rules. FDA “carries the burden of proving” the required speech is truthful and accurate, says attorney Jonathan Emord.

A federal court decision that an FDA regulation requiring graphic warnings on cigarette packaging is unconstitutional could have ripple effects in the pharmaceutical industry.

Lawyers say the decision in R.J. Reynolds Tobacco Company v. United States Food and Drug Administration could apply to other FDA rules, including its limits on dietary supplement...

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US FDA’s Prasad: ‘We Will Always Embrace Surrogate Endpoints’

 
• By Sarah Karlin-Smith

The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.

What Information Does US FDA Need For Stealth’s Elamipretide After CRL?

 
• By Sue Sutter

The agency said it will consider knee extensor muscle strength as a potential intermediate clinical endpoint to support accelerated approval, but Stealth CEO Reenie McCarthy said announcing it via complete response letter is confusing and inefficient.

UK And US Regulators In Sync On RWD External Control Arms

 
• By Vibha Sharma

The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.