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Labeling Regs Feel Ripple Effects From FDA’s Capsized Cigarette Warnings

 
• By Brenda Sandburg

A judge’s opinion that requiring graphic images on cigarette packages unconstitutionally compels speech could apply to FDA off-label rules and disclosure requirements.

A district 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...

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More from Legal & IP

More from Pink Sheet

EMA Explores Supporting Drug Development For High Unmet Need Disorder Scleroderma

 
• By Neena Brizmohun

While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.

EMA Nod For First MASH Drug Rezdiffra, Cell Therapy Zemcelpro And 11 Others

 
• By Eliza Slawther

Madrigal Pharmaceuticals’ Rezdiffra is on track to become the first medicine approved in the EU for non-cirrhotic metabolic dysfunction-associated steatohepatitis after the European Medicines Agency recommended that it be granted conditional marketing authorization.

BIO Notebook: Policy Uncertainty Constraining Dealmaking

 
• By Mandy Jackson and Joseph Haas

Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.