FDA Partially Rescinds Two Supplemental Biologics License Applications
The Center for Biologics Evaluation and Research (CBER), part of the U.S. Food and Drug Administration (FDA), partially rescinded two approvals of supplemental biologics license applications (sBLAs) for recombinant factor IX products. The sBLAs were approved by the...
Sinopharm Unit and CanSinoBio apply for Public Use Approval of COVID-19 Vaccine in China
Sinopharm, a unit of the China National Pharmaceutical Group, and CanSinoBiologics Inc both have applied in China for the public use of their COVID-19 vaccines. Currently, China has two approved vaccines that were developed within the country, and has yet to approve...
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 Clears Brainlab Loop-X Mobile Imaging Robot and Cirq Robotic Alignment Module
The U.S. Food and Drug Administration (FDA) cleared Brainlab’s Loop-X® Mobile Imaging Robot and Cirq®, a robotic surgical system. The clearance paves way for Brainlab to market in the U.S. market for both devices. Cirq robotic alignment module is meant for...
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...
FDA Grants Novartis Entresto® Expanded Indication for Chronic Heart Failure
The U.S. Food and Drug Administration (FDA) has granted Novartis’ Entresto expanded indication for chronic heart failure, making it the only drug therapy approved in the US to treat patients afflicted with guideline-defined heart failure. Approximately 83% of...
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