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.
Health Canada Implements ICH Pediatric Drug Development Guidance
Health Canada has adopted a nonclinical safety testing guidance to help develop medication in pediatrics. This guidance called GuidanceS11: Nonclinical Safety Testing in Support of Development of Pediatric Medicines has been developed by the ICH and is slated to be...
FDA Rejects Gilead’s Rheumatoid Arthritis New Drug Application
Gilead submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for filgotnib, a treatment for rheumatoid arthritis, which the FDA rejected due to safety concerns, particular in the 200mg dose. “We are disappointed in this outcome and will...
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...
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