1. Pink Sheet
  2. >>Legislation

US FDA’s Long Wait For Diagnostics Reform Legislation Continues

 
• By Michael McCaughan

FDA is hoping Congress might take up proposed legislation governing the regulation of diagnostic tests produced in laboratories in 2023. That will make it a full decade of stalemate since FDA outlined a framework to address the new reality of personalized medicine.

test tubes and microscope
• Source: Shutterstock

The US Food & Drug Administration is hoping that 2023 will finally be the year that Congress enacts legislation clarifying the agency’s authority to regulate lab-developed diagnostic tests.

FDA Deputy Commissioner for Policy, Legislation & International Affairs Andi Lipstein Fristedt offered a cautiously optimistic appraisal that diagnostic reform provisions could be enacted when Congress reauthorizes expiring user fee...

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 Legislation

EMA: ‘Sad To See’ Member States Against Patient Engagement Under EU Pharma Reform

 
• By Eliza Slawther

The European Medicines Agency’s chief medical officer Steffen Thistrup argued that patients are able to understand the “complex regulatory and scientific issues” that the EMA committees discuss when they assess drugs.

BIOSECURE Act Returning, Privacy, Gain-of-Function Bills Coming, Senate Sponsor Says

 
• By Laura Helbling

Legislation prohibiting work with certain Chinese biopharma firms will be reintroduced soon, Democratic Sen. Gary Peters said. And it will not be the only bill tied to international biotech competition and security concerns that will be considered.

Pharma DTC Ad Tax Break Targeted By US HHS, Congress

 
• By Derrick Gingery

Health and Human Services Secretary Robert F. Kennedy Jr. said a policy that would remove the tax write-off for pharma advertising expenses would be coming in a few weeks.

Korean Pharma Industry Proposes Policies As Election Nears

 
• By Jung Won Shin

As South Korea gears up for a snap presidential election, its biopharma industry proposes key desired policies to candidates, most of whom have not laid out detailed plans of their own for the sector.

More from Pink Sheet

EMA Touts Faster Global Post-Approval Changes Via Regulatory Reliance

 
• By Eliza Slawther

The European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.

UK And US Regulators In Sync On RWD External Control Arms

 
• By Vibha Sharma

The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.

New EU Approvals

 
• By Neena Brizmohun

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Vyjuvek, Krystal Biotech's advanced therapy for treating dystrophic epidermolysis bullosa.