Experts Question FDA Approval of Remdesivir for COVID-19
Experts are calling into question the recent decision of the U.S. Food and Drug Administration to approve remdesivir for the treatment of COVID-19.
FDA
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Read more: The Cost of Exclusion in Psychedelic Research The Cost of Exclusion in Psychedelic Research
The lack of diversity among research participants can have significant consequences on generalizability and distribution of treatments.
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Read more: COVID-19’s Impact on Clinical Trials: Meeting Participants Where They Are COVID-19’s Impact on Clinical Trials: Meeting Participants Where They Are
In light of COVID-19, a site and sponsor’s ability to flex to “meet the participant where they are” will be critical to the conduct of clinical trials.
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Read more: Is Real-World Health Algorithm Review Worth the Hassle? Is Real-World Health Algorithm Review Worth the Hassle?
The challenges of completing real-world performance review should not slow the FDA’s plans to regulate clinical algorithms.
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Read more: A New Step for the FDA in Regulating Digital Health Products A New Step for the FDA in Regulating Digital Health Products
On September 22, the U.S. Food and Drug Administration announced the establishment of a new initiative to regulate digital health products.
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Read more: Telehealth Policy Brought to the Fore in the COVID-19 Pandemic Telehealth Policy Brought to the Fore in the COVID-19 Pandemic
The COVID-19 pandemic has highlighted the value of telehealth as both a tool of necessity as well as of innovation.
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Read more: Racial Disparities Persist in Human Subjects Research Racial Disparities Persist in Human Subjects Research
Human subjects research has long been plagued by racial inequality. While flagrant abuses have been curtailed, disparities have, unfortunately, persisted.
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Read more: New Study Provides Insights into Potential Regulatory Treatment of COVID-19 Drugs New Study Provides Insights into Potential Regulatory Treatment of COVID-19 Drugs
Pandemics like COVID-19 certainly require the prompt approval of treatments, but efficacy and safety should not come at the cost of speed.
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Read more: Access to Drugs Before FDA Approval: Video Explainer with Christopher Robertson Access to Drugs Before FDA Approval: Video Explainer with Christopher Robertson
In this video explainer, Christopher Robertson discusses the Right to Try Act and off-label use of pharmaceuticals with Alison Bateman-House.
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Read more: Highlights from FDA Meetings on 3 Opioid-Related New Drug Applications Highlights from FDA Meetings on 3 Opioid-Related New Drug Applications
In January 2020, two FDA committees met to consider approval of three opioid-related new drug applications.
