Regulatory Affairs Professionals Society

FDA drafts guidance on using next-generation sequencing to assess gene therapy safety

The US Food and Drug Administration (FDA) has released draft guidance on how sponsors can utilize next-generation sequencing ...
News-Medical.Net

The FDA has released draft guidance for NAMs Validation – Now what?

On March 18th, the FDA published draft guidance on validating new approach methodologies (NAMs), including complex in vitro ...
Regulatory Affairs Professionals Society

Høeg touts FDA efforts to speed rare disease drugs to market

The top drug regulator at the US Food and Drug Administration (FDA) said the agency is working to develop new pathways for ...
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 ...
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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The U.S. Food and Drug Administration issued a draft guidance on Wednesday to help drug developers validate alternative methods that can be used in place of animal studies during early stages of drug ...
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 ...
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

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 ...
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, ...
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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 ...