Mushroom Monographs? The FDA’s Potential Role in a Legal Recreational Drug Market
How should the FDA regulate recreational drugs, if it has the power to do so?
us food and drug administration
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Read more: Mushroom Monographs? The FDA’s Potential Role in a Legal Recreational Drug Market -
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: FDA Approves Aducanumab for Alzheimer’s Disease: An Unethical Decision? FDA Approves Aducanumab for Alzheimer’s Disease: An Unethical Decision?
FDA’s approval of aducanumab may run against the bioethical principles of beneficence and non-maleficence.
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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: Aducanumab: A Bitter Pill to Swallow Aducanumab: A Bitter Pill to Swallow
Patients are understandably desperate, but their needs are best served by following the science, rather than lowering the standards for drugs.
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Read more: A Sensible, Evidence-Based Proposal for Kratom Reform A Sensible, Evidence-Based Proposal for Kratom Reform
Instead of fueling the long-failed War on Drugs by repressing kratom, the FDA should strengthen consumer confidence by creating uniform regulations.
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Read more: Expanding The Right to Try Unproven Treatments: A Dangerous, Deregulatory Proposal Expanding The Right to Try Unproven Treatments: A Dangerous, Deregulatory Proposal
As has been proven time and again, “gut feeling” and wishful thinking have never been shown to replace controlled clinical testing.
