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US FDA Action On Regenerative Medicine May Be Hindered If Court Sides With Stem Cell Clinics

 
• By Brenda Sandburg

Pew Charitable Trusts calls for FDA to take more aggressive enforcement against regenerative medicine products, but the outcome of a bench trial involving two stem cell clinics may limit what the agency can do.

Stem cells
Greater FDA enforcement action sought against stem stell clinics • Source: Alamy

The Pew Charitable Trusts is calling on the US Food and Drug Administration to ramp up its enforcement actions to protect patients from the marketing of unapproved regenerative medicine therapies. However, the FDA’s ability to do so may be hampered depending on the outcome of a bench trial that began last month.

On 1 June, Pew issued a report of its analysis of adverse event reports linked to unapproved stem cell and regenerative medicine interventions (SCRIs) outside of clinical trials. It identified reports of 360 people who had adverse events that occurred between 2004 and September 2020

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House Budget Bill Includes Delayed Orphan Fix, Also Risks Downstream Cell and Gene Coverage

 
• By Sarah Karlin-Smith

The first two classes of negotiated drugs under the Inflation Reduction Act would not benefit from a rare disease adjustment House Republicans included in their reconciliation package.

Keep Talking: US FDA’s Beleaguered Biologics Center Remains Vital To Regenerative Medicine

 
• By Bridget Silverman

Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.

Tougher Approval Standards May Follow Vinay Prasad’s Appointment To Lead US FDA’s CBER

 
• By Sarah Karlin-Smith

Industry is concerned that Prasad may make regulatory flexibility tougher to obtain for cell and gene therapy, while vaccine and public health advocates are angry about Prasad’s criticisms of US COVID-19 policies.

Sponsors Like START Rare Disease Pilot, Will Prasad Maintain Its Momentum?

 
• By Kate Rawson

Sponsors reported faster development times for products that joined the pilot program intended to speed rare disease treatments in CBER.

More from Advanced Technologies

EU Wants Industry To Define ‘Trade Secrets’ Under Health Data Sharing Regulation

 
• By Eliza Slawther

The European Health Data Space Regulation is deliberately “vague” when it comes to defining trade secrets because the EU wants the pharma industry to make recommendations on safeguarding intellectual property, a policy officer for the European Commission says.

Tougher Approval Standards May Follow Vinay Prasad’s Appointment To Lead US FDA’s CBER

 
• By Sarah Karlin-Smith

Industry is concerned that Prasad may make regulatory flexibility tougher to obtain for cell and gene therapy, while vaccine and public health advocates are angry about Prasad’s criticisms of US COVID-19 policies.

Sponsors Like START Rare Disease Pilot, Will Prasad Maintain Its Momentum?

 
• By Kate Rawson

Sponsors reported faster development times for products that joined the pilot program intended to speed rare disease treatments in CBER.