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.
FDA Propose Non-Invasive Bone Grown Stimulators Reclassifying from Class III to Class II
The US Food and Drug Administration (FDA) proposed reclassifying non-invasive bone grown stimulators from Class III to Class II, reducing the regulatory burdens and allowing the devices to be marketed with 501(k) clearance rather than requiring premarket...
Rare Disease Stakeholders Demand Regulatory Clarity
The Food and Drug Administration (FDA) asked for rare disease stakeholders, including individuals and families affected by rare disease(s), pharmaceutical companies, trade associations, and other federal agencies and regulators, to weigh in on a proposed clinical...
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...
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