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The FDA has released draft guidance for NAMs Validation – Now what?

On March 18th, the FDA published draft guidance on validating new approach methodologies (NAMs), including complex in vitro ...
Fierce Pharma

FDA lays out policy wish list, including new trial pathway and new enforcement powers

One year into his tumultuous tenure as the FDA’s commissioner, Marty Makary, M.D., has laid out ambitious internal goals and ...
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FDA push to replace animal testing signals major shift

WASHINGTON, D.C. — Federal regulators are moving to reduce the use of animal testing in drug development, issuing new guidance to help drugmakers adopt alternative methods that rely on human-based ...
Yahoo

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

Add Yahoo as a preferred source to see more of our stories on Google. FILE PHOTO: The corporate logo of the U.S. Food and Drug Administration (FDA) is shown in Silver Spring, Maryland, November 4, ...
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 ...
RAPS

FDA drafts guidance on animal testing alternatives

The US Food and Drug Administration (FDA) has released draft guidance aimed at assisting pharmaceutical manufacturers in transitioning from animal studies to non-animal alternatives for drug ...
Yahoo

New FDA guidance that’s a ‘huge deal’ for clinical trials

Add Yahoo as a preferred source to see more of our stories on Google. FDA headquarters in White Oak, Maryland (Sarah Silbiger via Getty Images) This story was originally published on PharmaVoice. To ...
Benzinga.com

DiNABIOS Applauds Historic U.S. Senate Passage of FDA Modernization Act 3.0, Advancing Human‑Relevant New Approach Methodologies (NAMs)

DiNABIOS Applauds Historic U.S. Senate Passage of FDA Modernization Act 3.0, Advancing Human‑Relevant New Approach Methodologies (NAMs) ZURICH/SCHLIEREN, Switzerland, December 24, 2025 – DiNABIOS AG, ...
JD Supra

FDA Publishes New Draft Guidance on Reducing Animal Testing in Nonclinical Safety Studies

The U.S. Food and Drug Administration (FDA) on Dec. 2, 2025, issued its draft guidance on Monoclonal Antibodies: Streamlined Nonclinical Safety Studies Guidance for Industry, the agency's most recent ...
Seeking Alpha

Inotiv Leverages LifeNet Health Proprietary Platform to Advance New Approach Methodologies in Translational Drug Discovery

WEST LAFAYETTE, Ind., Jan. 13, 2026 (GLOBE NEWSWIRE) -- Inotiv, Inc. (NOTV) (the “Company”, or “Inotiv”), a leading Contract Research Organization specializing in nonclinical and analytical drug ...
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US FDA pushes for new methods to replace animal testing in early drug studies

Under the new draft guidance, the FDA has recommended using newer non‑animal testing tools - known as new approach methodologies, or NAMs - when companies submit nonclinical safety data to support a ...