JD Supra

A Model’s Credibility Is in the Details: FDA Draft Guidance on the Use of AI Models in Drug and Biological Product Development

In January, the U.S. Food and Drug Administration (FDA) issued its first guidance on the use of artificial intelligence (AI)[1] models in drug development and in regulatory submissions titled, ...

Automated 3D heart tissue platform speeds up cardiac drug testing

Researchers from Leiden University Medical Center (LUMC) and the Leiden-based biotech company Ncardia have joined forces to ...
Fierce Healthcare

CMMI proposes new models to lower drug prices to international rates for Medicare Parts B, D

The Medicare Innovation Center has proposed two drug pricing models that would lower the cost of certain drugs to reflect international prices, which are often significantly lower than what U.S.
Nature

Beyond animal models: how organoids could transform drug development

For decades, the pharmaceutical industry has discussed moving away from in vivo models in preclinical research. Now, it’s more than a conversation. The FDA’s roadmap for reducing animal testing, ...
STAT

The end to animal testing marks the beginning of better biomedicine

Carlin is a vice president at Pathway Policy Group and a veterinarian. Paragas is the CEO and founder of DVLP Medicines and a virologist. The Food and Drug Administration’s recent decision to phase ...
News Medical

Microfluidic 3D-Organoid Platforms for Drug Screening and Toxicology

Organoid-on-chip technology merges patient-derived organoids with microfluidic engineering to recreate human physiology and predict drug responses with high precision. This innovation is reshaping ...
Forbes

CMS’ BALANCE Model Aims To Resolve Medicare Coverage Of Weight-Loss Drugs

Forbes contributors publish independent expert analyses and insights. Diane Omdahl is a Medicare expert who keeps her readers in the know. On December 23, the Centers for Medicare and Medicaid ...