Center for Disease Control (CDC) Adjusts Quarantine Guidelines
The U.S. Center for Disease Control (CDC) provided an alternative option to a 14-day quarantine standard, advising that patients with a negative test quarantine for 7 days, and those asymptomatic with no test results for 10. The adjustments were made in hopes to...
Review of Johnson & Johnson’s COVID-19 Vaccine Underway
After finding that the Johnson & Johnson vaccines triggered antibody cell formation to fight COVID-19, the European Medicines Agency (EMA) began to review the drug for emergency use authorization (EUA). Meanwhile, the company’s rivals Moderna and...
Moderna Requests FDA Emergency Use Authorization for mRNA-1273
Today (11/30) Moderna announced their plans to seek emergency use authorization from the U.S. Food and Drug Administration (FDA) for their COVID-19 vaccine candidate that reported a 94.1% efficacy rate. The study, that evaluated over 30,000 U.S participants,...
FDA Breakthrough Device List Includes Breast Cancer Treatment
A wide variety of medical technology devices are being more rapidly reviewed and tested for patient use through the U.S. Food and Drug Administration (FDA) Breakthrough Device List. Among the list of innovations are two breast cancer diagnostic tests along...
Essential Tremor Treatment Receives Funding from National Health Service (England)
INSIGHTEC, a global healthcare therapeutics company, has received funding from England’s public healthcare provider for their neurological disorder treatment, one that effects 41 million people globally. The treatment utilized acoustic sound energy, a...
WHO Declares Gilead’s COVID-19 Fighting Drug Ineffective
After an expert panel review of Gilead’s Remdesivir, no evidence was found that it was effective in treating COVID-19. In October, the U.S. Food and Drug Administration (FDA) granted the drug approval for usage in hospitals, and after rescinding the...
ABOUT US
CSOFT Health Sciences has over 15 years of experience providing end-to-end translation and localization solutions for all stages of the product life cycle, from pre-clinical to post-launch. We also specialize in China market access consulting services, Asian regulatory and eCTD submissions. Our operation is compliant with ISO 17100 and certified by BSI in ISO 9001:2015 and ISO 13485:2016, providing customized solutions to meet the rigorous regulatory requirements in global submission. For more information, please visit: www.csoftintl.com