Fortifying the US Pharmaceutical Supply Chain
Reducing dependency on any single nation must be a federal priority, but it can be accomplished only with industry stakeholder buy-in.
FDA
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Read more: Monthly Round-Up of What to Read on Pharma Law and Policy Monthly Round-Up of What to Read on Pharma Law and Policy
Selections feature topics ranging from political pressures facing the FDA, to the financial incentive structure for antibiotic development.
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Read more: Experts Question FDA Approval of Remdesivir for COVID-19 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.
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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.
