The next two weeks are busy ones for the U.S. Food and Drug Administration (FDA). Here’s a look at PDUFA dates for this period. Viela Bio’s Inebilizumab for NMOSD Gaithersburg, Maryland-based Viela Bio has a target action date of June 11 for its Biologics License…
Clinical Trials in Latin America – Challenges and Opportunities
Latin America has become a great ally for clinicians when developing Clinical Trials. This region provides many advantages and facilities other regions just can’t match. With over 20 countries spanning from Mexico in North America to Chile and Argentina in the South….
5 obstáculos a los que te enfrentarás al diversificar los ensayos clínicos
Minority participation in clinical trials is an important topic in public health discussions. This representation touches on issues of equality and the elimination of disparities, which are core values of the field. The FDA Safety and Innovation Act introduced in 2012,…
6 Reasons to Diversify Clinical Trials
Starting from the fact that minorities account for fewer than 10 percent of patients enrolled in clinical trials. Health disparities and underrepresentation in clinical trials could become a serious issue in the upcoming years. FDA Regulations In 2012 Congress included Section…
Psoriatic Arthritis Drug Shows Promise in Phase 3 Trial
In a pivotal phase-3 clinical trial led by a Stanford University School of Medicine investigator, patients with psoriatic arthritis for whom standard-of-care pharmaceutical treatments have provided no lasting relief experienced a significant reduction in symptoms, including joint tenderness and swelling, when…
Clinical Trials Diversity – More Minorities Needed to Make Research Relevant to All
Minorities, in fact, account for fewer than 10 percent of patients enrolled in clinical trials, according to the National Institutes of Health (NIH) National Institute on Minority Health and Health Disparities. Today, Wilkins brings together academic researchers and community members to…
Clinical Research in Ecuador | Diversity in Hispanic Community Involvement
Why Is Diversity Important? FDA Action Plan In 2012 the Food and Drug Administration Safety and Innovation Act was published. Most of this FDA Action plan is based to encourage researchers to include safety and effectiveness data by demographic subgroups, including…
Landmark Clinical Trial to Help Juvenile Idiopathic Arthritis Sufferers
A clinical trial funded by Arthritis Research UK and the National Institute for Health Research (NIHR), led by professors from the Universities of Liverpool and Bristol, has discovered a drug combination that could help thousands of children with Juvenile Idiopathic Arthritis….