1. Pink Sheet
  2. >>Archive

Sen. Burr’s Parting Gifts For US FDA Include ‘Platform’ Pathway

 
• By Michael McCaughan

The year-end package of US FDA reforms reflects the impact of one now-retired US Senator: North Carolina’s Richard Burr’s objections helped take out a number of ‘anti-innovation’ provisions – while still securing inclusion of a ‘Platform Technologies’ pathway that might otherwise not have been enacted.

Chromosome platform-perspectives
Sen. Burr's legislative work could help give birth to a regulatory pathway for gene therapy vectors and other platform technologies. • Source: Nielsen Hobbs; the Pink Sheet | Shutterstock images

The US Food & Drug Administration will have one year to outline a new “Platform Technologies” pathway for sponsors hoping to streamline development of products that rely on a common backbone (like a vector for gene therapies) to treat different diseases under the year-end spending bill expected to be enacted in the coming days.

The “Platform Technologies” pathway is included in the PREVENT Pandemics Act, which is in turn incorporated in the “Consolidated...

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 Archive

Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval

 
• By Neena Brizmohun

Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Nielsen Hobbs

This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Nielsen Hobbs

We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.

Brazil Pilots Digital Drug Pack Inserts

 
• By Francesca Bruce

A new pilot aims to take Brazil closer to ‘digital transformation.’

More from Pink Sheet

Semaglutide: EMA Safety Probe Confirms Rare Eye Disorder Risk

 
• By Neena Brizmohun

The EU product information for Novo Nordisk’s semaglutide medicines is to be updated to include non-arteritic anterior ischemic optic neuropathy as a side effect with a frequency of “very rare.”

Infographic: Leqembi – A Geographical Comparison

 
• By Anabel Costa-Ferreira

The Pink Sheet explores how regulatory approvals for Leqembi differ around the world, and looks at what is coming next.

EU Pharma Reform: Council Proposal A ‘Step In The Right Direction’ But ‘More Work To Be Done’

 
• By Eliza Slawther

Experts from EUCOPE explain why the Council of the EU’s position on the proposed overhaul of the general pharmaceutical legislation could offer more predictability for companies than the commission’s initial offering.