Another Chance For VALID? Negative Reaction To FDA’s LDT Proposal May Reopen Legislative Talks

All of the witnesses testifying to a House E&C Committee hearing said they preferred the flexibility and targeted enforcement of the VALID Act to FDA’s proposed rule. Will Congress finally be spurred to act?

congress
• Source: Shutterstock

Proponents of the VALID Act hope that the US FDA’s controversial proposed rule on laboratory-developed tests will bring lawmakers from both parties back to the negotiating table to find a legislative solution for oversight of LDTs, members of the House Energy & Commerce Health Subcommittee said during a 21 March hearing.

Rep. Larry Bucshon (R-Ind.), a co-sponsor on VALID with Diana DeGette (D-Colo.), called the bill a “carefully developed, well-vetted piece...

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

More from Legislation

Brazil To Fix Regulatory Reliance Shortfalls & Speed Up Approvals

 

Regulatory reliance processes for drug registration and clinical trial application approvals in Brazil have not met their “full potential,” says Brazil’s medicines regulator.

Proposed Shutdown-Ending Agreement Would Cut US FDA Non-User Fee Funding

 

But the Senate’s reduction would not be as much as the House of Representatives and President Trump proposed earlier this year, which is likely a win for the agency.

PDUFA VIII: FDA Pilot Programs, Workforce Challenges Could Shape Renewal Debate

 
• By 

The next iteration of the user fee program could depart from longstanding agency commitments to issue formal guidance given the Trump Administration’s deregulatory philosophy, policy experts said.

AI’s Attempt To Decode EU Pharma Reform Called A ‘Car Crash’

 

Sanofi’s EU regulatory science and policy head draws on a “nightmare” experience with using a generative AI tool to compare versions of the draft EU pharma reform text to explain the benefits and limitations of artificial intelligence tools in regulatory affairs.

More from Pink Sheet

‘Why We Would Do It Again’ – Gilead & Roche On Pioneering Global Initiative For Manufacturing Change

Gilead and Roche reflect on their experiences with a global initiative that delivered aligned regulatory decisions through joint hybrid inspections and synchronized review of post-approval changes.

Novel Alzheimer’s Drug Blarcamesine Scheduled For High-Stakes EMA Oral Explanation

 

The EMA has scheduled oral explanation meetings this week for Anavex’s blarcamesine and three other products that are nearing the end of the regulatory review cycle. These meetings usually represent the final chance for sponsors to persuade the agency that their product merits approval.

Sponsored by

The British Pharmacopoeia: Setting standards that are trusted worldwide

In this exclusive article with Peter Crowley, Secretary and Scientific Director of the BP Commission, you’ll discover how the BP is preparing for its landmark 2026 edition while strengthening its influence as a global bridge between science, regulation, and industry.