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 ...
Transcriptome-based NGS outperforms traditional viral testing with superior sensitivity, detecting viruses including novel ...
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 ...
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 ...
The FDA cleared its first in vitro test to help determine whether people showing signs of cognitive decline also carry one of the hidden hallmarks of Alzheimer’s disease. The diagnostic detects ...
The World Health Organization (WHO) has listed the first mpox in vitro diagnostic (IVD) under its Emergency Use Listing (EUL) procedure, an important step in improving global access to mpox testing.
Etelka is a post-doctoral research fellow exploring aerosol science with biology and engineering.View full profile Etelka is a post-doctoral research fellow exploring aerosol science with biology and ...
Common Mistakes to Avoid in Order to Improve Translation of Interaction Data to the Clinic Since 2006, when the U.S. FDA published a draft guidance on drug interaction studies, it has expected new ...
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