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

Unapproved Cell/Tissue Product Enforcement Discretion Ends; How Hard Will US FDA Crack Down?

 
• By Derrick Gingery

Entities that already have received letters from the agency raising concerns about marketing unapproved products may not necessarily be the first to face enforcement actions, CBER official says.

Person cracking a nut
Should sponsors expect a flurry of enforcement activity now that the FDA's discretion policy has ended? • Source: Alamy

The list of sponsors suspected of marketing unapproved human cell, tissue, and cellular and tissue-based products (HCT/P) that previously received notices from the US Food and Drug Administration may not represent the agency’s priority now that enforcement discretion has ended.

The most recent extension of the agency’s discretion policy expires 31 May and was not renewed. Sponsors of HCT/Ps without...

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

US FDA Compounding Advisory Panel Hit Hardest By Recent Purges

 
• By Sarah Karlin-Smith

A Pink Sheet review found 10 FDA advisory panel members recently pulled off committees despite having time left in their appointed terms.

US FDA Upheaval Forces User Fee Talks To Begin Later Than Usual

 
• By Derrick Gingery

The fall start of PDUFA and GDUFA negotiations could impact the agreement review process and other parts of the schedule intended to ensure it reaches Congress on time.

US FDA Leadership Changes Become Reality TV

 
• By Michael McCaughan

Suddenly the leadership changes at the US FDA’s Center for Biologics Evaluation & Research have begun to feel like a soap opera. That is not a recipe for regulatory predictability.

UK Must Pay ‘A Little Bit More, A Little Bit Earlier’ For Gene Therapies – CGT Catapult Chief

 
• By Eliza Slawther

If the UK is to become a top three country in the cell and gene therapy space, it must overcome the current political “stumbling block” around making changes that recognize the value of these therapies, Matthew Durdy, CEO of the Cell and Gene Therapy Catapult, tells the Pink Sheet.

More from Advanced Technologies

US FDA Leadership Changes Become Reality TV

 
• By Michael McCaughan

Suddenly the leadership changes at the US FDA’s Center for Biologics Evaluation & Research have begun to feel like a soap opera. That is not a recipe for regulatory predictability.

UK Must Pay ‘A Little Bit More, A Little Bit Earlier’ For Gene Therapies – CGT Catapult Chief

 
• By Eliza Slawther

If the UK is to become a top three country in the cell and gene therapy space, it must overcome the current political “stumbling block” around making changes that recognize the value of these therapies, Matthew Durdy, CEO of the Cell and Gene Therapy Catapult, tells the Pink Sheet.

‘We Need To Move With The Times’: Cell & Gene Therapy Catapult CEO On UK’s Regulatory Overhaul

 
• By Eliza Slawther

The UK drug regulator has introduced several changes in recent months, such as the introduction of a decentralized manufacturing regulation. Matthew Durdy, CEO of the Cell and Gene Therapy Catapult, explains what these changes mean for the cell and gene industry.