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 Places Mexican Hand Sanitizers on Import Alert
For the first time in history, the U.S. Food and Drug Administration (FDA) has placed a countrywide import alert for all hand sanitizers from Mexico due to concerns of methanol contamination. Hand sanitizers that are contaminated with methanol are known to result in a...
Japan’s PMDA Publishes Procedure for Conducting Remote Inspections
As an update to the previous release late last year, Japan’s regulatory body, the Pharmaceutical and Medical Device Agency (PMDA), has released its translated English version of the process for conducting remote compliance inspections for drugs and regenerative...
Australia’s Therapeutic Goods Administration Gives Provisional Approval for Pfizer’s COVID-19 Vaccine
Yesterday (1/25), Australia’s Therapeutic Good Administration (TGA) authorized Pfizer and BioNTech’s COVID-19 vaccine. The provisional approval is the first for COVID-19 vaccines in Australia’s market for individuals 16 years and older and is expected to be...
FDA Approves First Oral Medication for Lupus Nephritis
The U.S. Food and Drug Administration (FDA) announced on Friday (1/22) the first ever approval for Aurinia Pharmaceutical’s Lupkynis oral medication in combination with a background immunosuppressive therapy regimen for lupus nephritis (LN), serious chronic autoimmune...
Curelator and University of Calgary Study Finds a Lack of Association Between Migraines and Stress Levels
Curelator, a digital health company based in Cambridge, MA, released its findings for the largest international study that focused on the relationship between stress and migraines in the January issue of Headache, The Journal of Head and Face Pain in collaboration...
Australia’s TGA Takes First Steps in Approving Novavax COVID-19 Vaccine
Yesterday (1/20), Novavax received provisional determination from Australia’s Therapeutic Goods Administration for its COVID-19 vaccine, marking the first steps in gaining provisional approval. Australia’s provisional approval pathway allows for drug therapies (or...
The Importance of Quality Translation for the 2021 EU MDR Deadline
On May 26th 2021, the European Union’s Medical Device Directive (MDD) (93/42/EEC) and Directive on Active Implantable Medical Devices (90/385/EEC) will be replaced and fully covered by the Medical Device Regulation (MDR). Since the original medical device directive’s...
Seneca Biopharma Announces Results for Treatment of Ischemic Stroke in Phase 2 Clinical Trial
Seneca Biopharma announced today (1/20) its preliminary top-line results for their Phase 2 ischemic stroke study. The trial, which took place in Beijing, China, focused on evaluating the relative safety of NSI-566, a neural stem cell therapy, in patients afflicted...
FDA Releases AI/ML Five-Part Action Plan for SaMD
The U.S. Food and Drug Administration (FDA) released its artificial intelligence/machine learning five-part action plan for software as a medical device (SaMD). The FDA announced in the plan its intention to create a tailored regulatory framework for SaMD, as well as...
EMA Issues Draft Guidance Parallel to Article 58 and Centralized Authorization Reviews
The European Medicines Agency (EMA) issued a draft guidance yesterday (1/14) for medicines intended to be used in low- to middle-income countries outside the European Union (EU). The Article 58 process calls for EMA’s Committee for Medicinal Products for Human Use...
Categories
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