A Pseudo-Nonprofit Model for Psychedelic Clinical Trial Funding
Funding for psychedelic research may increasingly rely on nonprofit and commercial partnerships.
pharmaceutical
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Read more: Reasonable Pricing Clauses: A First Step Toward Ensuring Taxpayers a Fair Return on their Public R&D Investment Reasonable Pricing Clauses: A First Step Toward Ensuring Taxpayers a Fair Return on their Public R&D Investment
Reasonable pricing clauses are needed to ensure that American taxpayers receive a fairer return on their investment for essential therapies.
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Read more: Book Review: ‘Drugs and the FDA: Safety, Efficacy, and the Public’s Trust’ by Mikkael A. Sekeres Book Review: ‘Drugs and the FDA: Safety, Efficacy, and the Public’s Trust’ by Mikkael A. Sekeres
“Drugs and the FDA” is a must-read for anyone interested in how the FDA became the trusted regulatory agency it is today.
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Read more: To Address the Overdose Epidemic, Tackle Pharma Industry Influence To Address the Overdose Epidemic, Tackle Pharma Industry Influence
To combat the opioid epidemic, we have to understand how regulators failed to protect the public health as the market for prescription opioids grew.
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Read more: Why Do Differences in Clinical Trial Design Make It Hard to Compare COVID-19 Vaccines? Why Do Differences in Clinical Trial Design Make It Hard to Compare COVID-19 Vaccines?
Because of differences in how they were tested in clinical trials, it is difficult to make apples-to-apples comparisons for COVID-19 vaccines.
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Read more: “Stick to the Science”? FDA, Ethics, and Pandemics “Stick to the Science”? FDA, Ethics, and Pandemics
This post reflects on the ethical implications of FDA’s use of its emergency powers, and suggests opportunities for greater accountability moving forward.
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Read more: What’s the Difference Between Vaccine Approval (BLA) and Authorization (EUA)? What’s the Difference Between Vaccine Approval (BLA) and Authorization (EUA)?
A Biologics License Application, or BLA, is FDA’s standard “full approval” mechanism for biological products, including therapeutics and vaccines.
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Read more: How Can Policymakers Overcome the Hurdles to Scaling up Antibody Manufacturing? How Can Policymakers Overcome the Hurdles to Scaling up Antibody Manufacturing?
The difficult manufacturing issues involved in the therapeutic antibody context, and what might be done to address them.
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Read more: Why Aren’t Therapeutic Antibodies Being Used More to Treat COVID-19? Why Aren’t Therapeutic Antibodies Being Used More to Treat COVID-19?
The rapid development of therapeutic antibodies is a triumph of biomedical innovation. But they won’t help unless they make it to patients.
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Read more: What Can Policymakers Learn from the Slow COVID-19 Vaccine Rollout? What Can Policymakers Learn from the Slow COVID-19 Vaccine Rollout?
In this post we explain what went wrong and how policymakers can correct course for COVID-19 and avoid such disasters in the future.
