On , The US Food and Drug Administration issued draft guidance identifying specific types of monoclonal antibody products for which the agency believes six-month toxicity testing in non-human primates ...
Facility design should integrate risk mitigation strategies, focusing on contamination prevention and reliable utility ...
The FDA approved Cleveland Diagnostics' blood-based test to help diagnose high-grade prostate tumors and aid in biopsy decisions, the company announced.
The FDA has granted premarket approval (PMA) to the IsoPSA test, a novel, blood-based in vitro diagnostic kit designed to ...
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