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.
First-Ever Valve Approved by FDA for Congenital Heart Disease
The U.S. Food and Drug Administration (FDA) approved of the first-ever valve for treating pulmonary valve regurgitation in patients with certain kinds of congenital heart disease. The device, called Harmony Transcatheter Pulmonary Valve (TPV) has been granted...
Takeda’s Dengue Vaccine Begins Regulatory Submissions
Takeda's dengue vaccine candidate's filing packages has been accepted by the European Medicines Agency (EMA), which is being investigated for its prevention of dengue in individuals between the ages of 4 and 60. Takeda also submitted the vaccine for regulatory...
LetsGetChecked’s COVID-19 At-Home Test Approved by FDA
The U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) LetsGetChecked's COVID-19 at-home test to sell directly to consumers at retail stores as well as online. Peter Foley, CEO and Founder of LetsGetChecked stated, “While the...
Merck Granted Label Expansion by FDA for Keytruda
Keytruda, Merck's checkpoint inhibitor, has been granted label expansion by the U.S. Food and Drug Administration (FDA) for first-line treatment for patients diagnosed with, regardless of PD-L1 expression, locally advanced or metastatic gastroesophageal or esophageal...
FDA Grants EUA to Beckman Coulter’s COVID-19 Antibody Test
The U.S. Food and Drug Administration (FDA) granted emergency use authorization (EUA) to a COVID-19 antibody test created by Beckman Coulter. The antibody test measures the level of antibodies in a patient in response to COVID-19 to provide both a qualitative as well...
Study Shows AstraZeneca Vaccine Ineffective Against South African Variant
The New England Journal of Medicine published results from a study to test AstraZeneca's vaccine's efficacy for the South African variant of COVID-19. The clinical study was conducted in South Africa with 1,467 participants, of which 2.5% developed mild-to-moderate...
FDA Provides Smooth Pathway for COVID-19 Screening Tests
The U.S. Food and Drug Administration (FDA) is providing further guidance and a smoother path for COVID-19 screening tests, specifically for asymptomatic patients. Part of this process includes the release of a fact sheet for those interested in organizing screening...
EMA Offers Guidance on Labeling for COVID-19 Therapeutics
The European Medicines Agency (EMA) offered guidance on labeling requirements for COVID-19 therapeutics as a follow up on their guidance from last year that offered labeling requirement flexibilities on COVID-19 vaccinations. According to the EMA, the product's...
E-Labeling for the Life Sciences Industry
There has been a drastic increase in regulations surrounding labeling for medical devices over the past decade. As our world shifts towards a more digital landscape, e-labeling, which is an electronic version of an Instruction for Use (IFU), has become more popular...
FDA Grants Approval for Medtronic’s Labeling of Intellis™ Platform
The U.S. Food and Drug Administration (FDA) granted approval for revised commercial labeling of Medtronic's Intellis™ Platform with Differential Target Multiplexed (DTM™). The platform is meant to treat chronic and intractable leg and back pain. Charlie Covert, VP and...
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