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CSOFT’s health sciences blog aims to provide a better understanding of complex diseases, and regulatory polices from conducting experiments to introducing new type of drugs into the market.

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FDA Makes Recommendations for COVID-19 Variants

FDA Makes Recommendations for COVID-19 Variants

The U.S. Food and Drug Administration (FDA) has revealed recommendations for drug developers and diagnostic test makers to address the efficacy and overall performance of their products in consideration of the COVID-19 variants. The updates in recommendations are...

FDA Approves First Ever 3D-Printed Bone Replacement

FDA Approves First Ever 3D-Printed Bone Replacement

The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has granted approval for the first customized 3D-printed bone replacement. The device, named Patient Specific Talus Spacer, is the only 3D-printed device in the world, and...

AstraZeneca-Oxford COVID-19 Vaccine is Granted EUA by WHO

AstraZeneca-Oxford COVID-19 Vaccine is Granted EUA by WHO

The World Health Organization (WHO) announced yesterday (2/15) its approval of emergency use authorization (EUA) of the AstraZeneca-Oxford COVID-19 vaccine. The vaccine is currently approved in the UK and EU, and the WHO’s approval opens more doors for other nations...

FDA Grants EUA for New Molecular COVID-19 Diagnostic Test

FDA Grants EUA for New Molecular COVID-19 Diagnostic Test

The U.S. Food and Drug Administration (FDA) granted BD Emergency Use Authorization (EUA) for a new molecular diagnostic test for COVID-19 and the Influenza A+B virus that provides results within 2-3 hours. The test has already been CE marked for the IVD Directive....

J&J Submits Single Dose COVID-19 Vaccine to FDA

J&J Submits Single Dose COVID-19 Vaccine to FDA

Janssen Biotech, a Johnson & Johnson company, submitted an Emergency Use Authorization (EUA) application to the U.S. Food and Drug Administration (FDA) for its single dose COVID-19 vaccine. The submission is based on topline safety and efficacy data from the Phase...