【CAPED News】Good Clinical Practice (GCP) Requirements for Data Submitted from Clinical Investigations for In Vitro Diagnostic (IVD) Device Premarket Submissions
March 1, 2024
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
【CAPED News】EU Takes Steps to Prevent Medical Device Shortages
February 28, 2024
In response to ongoing concerns about medical device shortages, the European Union (EU) Council has endorsed new measures aimed at addressing these challenges. The agreed-upon revisions not only focus on preventing shortages but also include updates to registration procedures for
【CAPED News】FDA OKs First Interchangeable, High-Concentration Humira Biosimilar
February 27, 2024
The US Food and Drug Administration has approved the first interchangeable, high-concentration, citrate-free adalimumab biosimilar, adalimumab-ryvk (Simlandi). This is the 10th adalimumab biosimilar approved by the regulatory agency and the first biosimilar approval in the US market for the Icelandic
Picture of COVID-19 in Europe Is Complex
January 15, 2024
“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
South America Dengue Spike Prompts Vaccination Drive as Bug Spray Runs Out
January 10, 2024
South America is seeing a surge in cases of the mosquito-borne disease dengue during the southern hemisphere summer.Brazil this month has started spraying insecticide from trucks, while hospitals in Paraguay have set up night clinics to attend to the sick
Pandemic Disruption Adversely Affected People With Diabetes
January 5, 2024
For people with diabetes, disruption from the COVID-19 pandemic led to higher rates of death and other adverse outcomes, particularly diabetic ketoacidosis (DKA) in children, new research found. The data came from what was believed to be the first systematic review of
Why are cases of HIV infections on the rise among girls?
January 2, 2024
According to a recent global snapshot released by UNICEF, the burden of HIV disproportionately falls on adolescent girls and children in certain regions of the world. Although children and adolescents aged 19 and below account for only 7% of HIV
Helicobacter pylori: Unraveling the Hidden Culprit in Stomach Health
December 25, 2023
Have you ever heard of a bacterium that can quietly reside in your stomach, causing a range of digestive problems? Meet Helicobacter pylori (H. pylori), a fascinating yet concerning microorganism that affects millions worldwide. The Stealthy Invader: H. pylori is a
JN.1: The New COVID-19 Variant
December 18, 2023
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
5 Facts You Need to Know about Mycoplasma pneumoniae
December 12, 2023
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
Stay Alert: Ticks Can Still Pose a Threat in Winter
December 4, 2023
Experts warn that while most bugs die in the winter, ticks remain active and pose a growing threat as the climate warms. These bloodsucking pests are resilient to freezing temperatures and take advantage of temporary warm spells to seek hosts,
Unknown Respiratory Illness in Dogs: What You Need to Know
November 22, 2023
In certain states of the United States, dogs have been infected by an unidentified respiratory illness. The specific cause of this illness remains unknown. While there appears to be a viral connection among these cases, most standard respiratory diagnostic tests