BioProcess International

Have We Finally Reached the End of In Vitro Testing? Positioning NGS in Your Biosafety Testing Strategy

Transcriptome-based NGS outperforms traditional viral testing with superior sensitivity, detecting viruses including novel ...
Nature

In Vitro Skin Irritation Testing and Assessment

In vitro skin irritation testing has emerged as a critical component in the safety evaluation of chemicals and medical devices, aiming to replace traditional animal-based assays. Central to this ...
JD Supra

The Devil Is in the Details: Bioequivalence, In Vitro Testing Not Enough to Establish Infringement

Addressing for the first time the issue of whether bioequivalence data and in vitro testing can show that an abbreviated new drug application (ANDA) product with different immediate and delayed ...
Yahoo

Federal Court 'Vacates in Its Entirety' the FDA's Costly and Onerous Lab Test Rule

A federal district court has struck a blow for medical innovation and patient empowerment by overruling the Food and Drug Administration's (FDA) misbegotten effort to regulate laboratory-developed ...

Osmo and IIVS Publish First-of-its-Kind Study on AI-Powered Skin Irritation Assessment, Eliminating Need for Animal Testing

Osmo and IIVS Publish First-of-its-Kind Study on AI-Powered Skin Irritation Assessment, Eliminating Need for Animal Testing ...
The National Law Review

The Devil Is in the Details: Bioequivalence, In Vitro Testing Not Enough to Establish Infringement

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...