Animal Testing Alternatives Need Central Office At US FDA, Science Board - Clone

Slow adoption of alternatives to animal testing in the current decentralized regulatory framework shows the need for a ‘one-stop shop’ at FDA that can provide advice, precedents and qualification programs.

Organ on a chip
Animal testing alternatives like organ on a chip soon could see more use in drug development. • Source: Shutterstock

To better handle the growth of technologies intended to reduce the need for animal testing for regulatory decisions, a US Food and Drug Administration Science Board subcommittee suggested the agency establish a new central office to oversee so-called new alternative methods (NAMs) in the commissioner’s office.

Key Takeaways
  • A US FDA Science Board report recommends establishing a central office for new alternative methods (NAMs) in the FDA commissioner’s office.

The New Alternative Methods Subcommittee presented its recommendations at the Science Board’s 7 October meeting, a year after the...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight 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 Medtech Insight

Edwards Lifesciences Lowers Tariff Impact Forecast, Keeps Gross Margin Guidance Intact

 
• By 

The company reaffirmed its guidance for adjusted gross profit margin for the full year 2025 to remain within the original range of 78% to 79%. Chief financial officer Scott Ullem attributed this to currency and tariff dynamics.

Olympus, Revival Co-Found Swan In $458M Deal, Face Tech and Regulatory Hurdles

 
• By 

Olympus and Revival Healthcare Capital have launched Swan Endosurgical in a $458m milestone-based joint venture to develop a robotic platform for endoluminal surgery. The deal combines Olympus’ GI expertise with Revival’s start-up model, but will face technical and regulatory hurdles.

Alternative Funding Sources Emerge Amid Biotech Industry Challenges

 
• By 

The biotech funding landscape is undergoing a fundamental shift. With traditional VC becoming increasingly cautious and selective, industry executives are exploring new avenues for capital. Conversely, this evolution may ultimately benefit the sector's long-term sustainability.

NHS Orders Halt On Unapproved AI Scribes, Vendors Rush To Self-Certify

 

The NHS England chief clinical information officer issued a cease and desist on unapproved ambient voice technology and AI scribes. The move caused confusion among AVT vendors and went beyond joint MHRA/NHS guidance. IMed consultant Ben Austin shares his perspective.

More from Policy & Regulation

From ‘Work Harder’ to ‘Phenomenal People’: Makary’s FDA About-Face

 

In his first 100 days as FDA commissioner, Martin Makary has gone from vocal critic to vocal supporter of the agency’s staff, calling them “phenomenal” and praising their dedication—even as morale remains shaken by recent layoffs and restructuring.

Time For Medtech To Have Its Say On Critical Changes In EU Framework Legislation

 

In revising the foundations of EU product legislation, the European Commission aims to increase harmonization, cut regulatory burdens and promote digital tools to boost compliance and safety.

HHS Suggests Drastic Reductions To Skin Substitute Payments

 
• By 

The US Department of Health and Human Services has proposed cutting Medicare reimbursement for skin substitutes used in chronic wound care by up to 90%. The change aims to address rising costs but could harm patient access and treatment quality, prompting concerns from industry stakeholders.