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【CAPED News】Good Clinical Practice (GCP) Requirements for Data Submitted from Clinical Investigations for In Vitro Diagnostic (IVD) Device Premarket Submissions

The FDA has established human subject protection regulations addressing requirements for informed consent and Institutional Review Board (IRB) review that apply to all clinical investigations of devices involving human subjects, including deidentified human specimens. Investigations of medical devices involving human specimens, including

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Picture of COVID-19 in Europe Is Complex

“COVID is here to stay,” emphasized World Health Organization (WHO) Regional Director for Europe, Hans Kluge, MD, at a press briefing on January 16, 2024. He stressed the need for continuing vigilance and efforts to keep the disease at the top of

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JN.1: The New COVID-19 Variant

JN.1 is a COVID-19 variant that has emerged as “another Omicron variant” and is believed to have descended from the BA.2.86 variant. JN.1 has been reported in several countries, including the U.S., Iceland, Portugal, Spain, the Netherlands, and its frequency

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5 Facts You Need to Know about Mycoplasma pneumoniae

In recent times, there has been a notable increase in cases of pediatric pneumonia linked to Mycoplasma pneumoniae (MP) in several countries, including China, Denmark, France, the Netherlands, and specific regions in the United States. This rise has raised concerns on

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