1. Pink Sheet
  2. >>Advanced Technologies
  3. >>Cell & Gene Therapies

US FDA's Drug Seizures Seen As Most Significant Aspect Of Stem Cell Crackdown

Former Office of Compliance and Biologics Quality Deputy Director Mark Schwartz says dishonest players have not often seen serious enforcement actions from the agency.

Seizure of property. Yellow warning tapes with inscription "SEIZURE OF PROPERTY"

Stem cell manufacturers have rarely been subject to aggressive US FDA enforcement actions, but Commissioner Scott Gottlieb's recent announcement about a crackdown on unscrupulous companies in the regenerative medicine industry along with the seizure of product from a California facility could signal a meaningful change in how the agency targets dishonest industry players, a former FDAer says.

The Center for Biologics Evaluation and Research (CBER) has not often directed the seizure of unapproved product as it did in August with the confiscation of five vials of a live vaccinia virus vaccine at the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, Calif

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Cell & Gene Therapies

Keep Talking: US FDA’s Beleagured 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.

Potency Assay Issues Delayed US FDA Approval Of Mesoblast’s Ryoncil For Years

 
• By Sue Sutter

The company’s failure to show its potency assays measured attributes directly related to the mesenchymal stromal cell product’s therapeutic effect highlights the importance of a robust CMC program for complex cell therapies.

More from Advanced Technologies

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.

What The EMA Can Teach HTA Bodies About Joint Clinical Assessments

 
• By Francesca Bruce

EU-level joint clinical assessments conducted under the Health Technology Assessment Regulation need to be more flexible when it comes to evidence requirements, according to experts speaking at a gene and cell therapy conference.

Canada’s HTA Agency Reveals How To Submit AI-Driven Evidence

 
• By Neena Brizmohun

Recognizing that the evidence it receives in applications for health technology assessments will increasingly be informed by artificial intelligence, the CDA-AMC has clarified its expectations for companies that use AI methods in the generation and/or reporting of evidence.