EurekAlert!

ISSCR Consortium urges FDA to maintain flexible, science-driven framework for new approach methodologies in drug development

The International Society for Stem Cell Research (ISSCR) Consortium on Advanced Stem Cell-Based Models in Drug Discovery and Development has submitted comments to the U.S. Food and Drug Administration ...
Health AffairsOpinion

Refining FDA’s Plausible Mechanism Framework, Part 1: Understanding The Draft Guidance And Clarifying The Framework’s Scope

This is part one of a two-part article offering proposals to improve the FDA’s guidance to implement a new approval framework ...
Regulatory Affairs Professionals Society

FDA oncology draft guidance aims to reduce animal testing

The US Food and Drug Administration (FDA) has proposed guidance to reduce the need for animal testing in the development of ...

FDA Issues Draft Guidance to Cut Unnecessary Animal Testing for Cancer Drugs

The U.S. Food and Drug Administration today issued a draft guidance to reduce unnecessary animal testing in nonclinical safety assessments for certain cancer drugs. “This draft guidance not only ...
News Medical

How new approach methodologies and regulation are shaping safer, more predictive therapeutics outcomes

As regulatory authorities accelerate the use of New Approach Methodologies (NAMs), the drug discovery landscape is changing dramatically. This webinar explores how NAMs, immunology-driven platforms, ...
Seeking Alpha

FDA issues guidance on alternatives to animal testing

The U.S. Food and Drug Administration issued a draft guidance on Wednesday to help drug developers validate alternative methods that can be used in place of animal studies during early stages of drug ...
Medical Xpress

New paper urges caution as FDA plans to phase out animal testing in drug development

Replacing animal testing with alternate methodologies in preclinical drug trials holds potential for the development of cheaper, safer pharmaceuticals as well as alleviating animal suffering. But ...
Healio

FDA efforts to reduce animal testing signal shift toward AI, organ-on-chip study methods

Please provide your email address to receive an email when new articles are posted on . The FDA announced plans in 2025 to reduce animal testing requirements in biomedical research. New approach ...
Reuters

US FDA pushes for new methods to replace animal testing in early drug studies

March 18 (Reuters) - The U.S. Food and Drug Administration on Wednesday issued a draft guidance to help companies reduce animal studies of experimental drugs and adopt newer methods, such as computer ...
MedCity News

The Changing Landscape of New Approach Methodologies

The past year has marked a turning point for New Approach Methodologies (NAMs) in preclinical drug development. No longer experimental curiosities, these human-relevant approaches have rapidly gained ...
Duke Today

New Drug Delivery Approach for GLP-1 Drugs

Duke biomedical engineers have developed a new way to deliver a broad range of peptide-based drugs orally that works as well ...
EurekAlert!

New paper urges caution as FDA plans to phase out animal testing in drug development

Phasing out animal testing in preclinical drug trials in favor of unvalidated alternate methodologies could ultimately backfire and raise safety and effectiveness concerns, says Sara Gerke, the ...