27 Mar US FDA releases draft guidance for cancer clinical trials
The US Food and Drug Administration (FDA) has issued draft guidance aimed at improving oncology clinical trials for accelerated approval....
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27 Mar FDA greenlights first drug for immunodeficiency disease
The FDA approved leniolisib as the first treatment indicated for activated phosphoinositide 3-kinase delta syndrome (APDS), a rare genetic disorder that causes progressive primary immunodeficiency....
25 Mar Health inequity should be labeled as a ‘never event’
While increased awareness of disparities has improved our understanding of differences in health outcomes related to race, ethnicity, language, and other demographic factors, there remains limited reduction in healthcare disparities....
24 Mar FDA outlines plan for digital health technologies for clinical trials
The US Food and Drug Administration (FDA) plans to hold at least one public meeting and release several guidances on digital health technologies (DHT) to be used in drug clinical trials by the end of the year....
24 Mar US FDA proposes higher bar for accelerated approvals for cancer drugs
The U.S. health regulator on Friday proposed cancer drug developers in most cases conduct more rigorous trials to seek accelerated approval for their candidates....
23 Mar Preparing for the future of clinical trials
Generating evidence by integrating research into patient care....
21 Mar Responding to FDA inspections in an era of closer scrutiny
Many changes were made to the FDA's requirements for clinical research during the pandemic, including adoption of decentralized clinical trial elements. How will this affect future inspections....
20 Mar Ask a Doctor: Should I join a clinical trial?
A doctor who leads clinical trials explains the goals of this type of research and what questions you should ask before joining....
15 Mar Race/ethnicity are underrepresented in dermatology trials
Researchers discovered race/ethnicity underrepresentation during an analysis of over 100 dermatology-focused clinical trials....
14 Mar Celebrating progress for women in clinical research
In addition to an expanding role as participants in trials, women are leaders at stakeholder organizations, skilled clinical research professionals, and passionate advocates for female representation in clinical research....