The Patent Trial and Appeal Board Again Survives Supreme Court Review
For the generic drug and biosimilar industries, the Supreme Court’s recent decision in United States v. Arthrex, Inc. comes as a relief.
Pharmaceuticals
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Read more: The Patent Trial and Appeal Board Again Survives Supreme Court Review -
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: 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: Monthly Round-Up of What to Read on Pharma Law and Policy Monthly Round-Up of What to Read on Pharma Law and Policy
Interesting empirical studies, policy analyses, and editorials on health law and policy issues from the month of May 2021.
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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.
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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
Interesting empirical studies, policy analyses, and editorials on health law and policy issues from the month of April 2021.
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Read more: US Support for a WTO Waiver of COVID-19 Intellectual Property – What Does it Mean? US Support for a WTO Waiver of COVID-19 Intellectual Property – What Does it Mean?
An explanation of the WTO waiver of COVID-19 intellectual property, what the U.S. declaration of support means, and likely effects of the waiver.
