Health
CSOFT’s health blog aims to provide insight into complex diseases, treatment options and regulatory developments, and other prevalent health issues people face today.
The Importance of Regulatory Translation in the Life Sciences
For businesses in the life sciences looking to globalize their product or service, accurate and high-quality regulatory translation is essential for market access and success. Companies creating innovative, lifesaving or life enhancing drug therapies and devices,...
Linguistic Validation: What You Need to Know
Linguistic validation is a technique of reviewing and validating the accuracy, reliability, and equivalency for measurements of patient-reported outcomes (PROs). These outcomes, directly reported by patients, help determine the usefulness and efficacy of various...
Russia Announces Approval of COVID-19 Vaccine
Vladimir Putin announced on yesterday (8/11) of Russia’s approval for COVID-19 vaccine, “Sputnik V”. The approval comes before the vaccine has completed its final stages in the clinical trials, causing worry from both inside and outside the country. The first round of...
FDA Provides New Guidance for Drug-Drug Interaction Studies of Therapeutic Proteins
The US Federal Drug Administration (FDA) with the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) has provided guidance today (8/10) for drug-drug interaction studies of therapeutic proteins. The guidance...
How Technology is Enabling Patients’ Voices to be Heard in Clinical Research
COVID-19 has forced most of the world to work remotely, causing a major disruption in clinical research and the drug development process. As a result, the need for centralized and advanced patient engagement technology to better healthcare for all parties involved,...
Pfizer Signs Multiyear Agreement to Make Gilead’s Covid Treatment Remdesivir
Pfizer announced today (8/7) that it has signed a multiyear agreement for Gilead’s remdesivir, a treatment for Covid. With Gilead aiming to produce enough remdesivir to treat more than 2 million patients by the end of the year, and agreeing to send almost the entirety...
FDA Issues EUA for Vela Diagnostics Covid PCR Test
The FDA issued yesterday (8/5) Emergency Use Authorization for Vela Diagnostics for the manual version of their Covid PCR test. The manual version of the test enables flexible sample processing, facilitating widespread use of the test throughout the United States. Sam...
FDA Approves of RedHill Pharma Phase 3 Study for NTM Infection
The FDA approved today (7/31) RedHill Biopharma’s investigational new drug (IND) application for phase 3 of RHB-204 for pulmonary NTM infection in adults. NTM (nontuberculous mycobacteria) is a chronic lung disease caused by environmental bacteria typically near...
Augmented Reality and Virtual Reality in Healthcare: Opening New Possibilities for Efficient Care Delivery
Across industries, including healthcare, professional translation and localization services are essential to bringing innovative products to consumers across linguistic and national borders. For the healthcare industry, however, the stakes are often much higher, as...
US House of Representatives Approves $3.2 Billion for FDA Budget
The US House of Representatives approved of a $3.2 billion budget for the FDA for the 2021 fiscal year, a $40.8 million increase from the 2020 fiscal year. The additional funding is meant to support new initiatives for greater collaboration across departments within...
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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