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FDA Court Loss Shows ‘Disconnect’ Between Old Regulatory Language And Cell Therapy Technology

 
• By Brenda Sandburg

That statutory regulatory language never quite keeps up with change in science is an ‘existential crisis,’ former FDA official says. California district court ruling preventing FDA enforcement action against stem cell clinics was ‘a little bit disrespectful to the agency.’

Disconnect maze
The gap between old regulatory langage and new technology is problematic for FDA regulation of stem cell treatments • Source: Shutterstock

A district court judge’s ruling that the US Food and Drug Administration could not prevent two stem cell clinics from administering unapproved stromal vascular stem cell treatments shows how difficult it is for the agency to regulate novel products.

Eva Temkin, a partner at King & Spalding, noted that one of the problems for the FDA is that it...

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Center for Biologics Evaluation and Research Director Vinay Prasad said Commissioner Martin Makary wants to release previously inaccessible FDA documents, but previous commissioners have made the same pronouncements only to make little progress.

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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

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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.