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.
Pharmaceuticals
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Read more: Book Review: ‘Drugs and the FDA: Safety, Efficacy, and the Public’s Trust’ by Mikkael A. Sekeres -
Read more: What Happened to the COVID-19 Vaccine Patent Waiver? What Happened to the COVID-19 Vaccine Patent Waiver?
The negotiations leading to the WTO Decision proved once again the inadequacy of the debate over intellectual property rights.
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Read more: How the Unpredictable Long-Term Effects of COVID-19 Infection Pose a Challenge That Tort Law Cannot Meet How the Unpredictable Long-Term Effects of COVID-19 Infection Pose a Challenge That Tort Law Cannot Meet
Statutes of limitation present a significant hurdle for plaintiffs experiencing harms from COVID-19 infection.
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Read more: Everything You Wanted to Know About Expanded Access but Were Afraid to Ask, Part 3 Everything You Wanted to Know About Expanded Access but Were Afraid to Ask, Part 3
Once sponsors decide to capture/share expanded access-derived data above and beyond that needed, what should IRBs do?
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Read more: Accessing COVID-19 mRNA Vaccines for Research: The Re-emergence of the Tragedy of the ‘Anticommons’ Accessing COVID-19 mRNA Vaccines for Research: The Re-emergence of the Tragedy of the ‘Anticommons’
COVID-19 vaccine manufacturers refusing to share samples may be the latest example of the tragedy of the “anticommons” in biomedical research.
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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 September 2022.
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Read more: Sweet Land of Immunity Sweet Land of Immunity
But in the crisis, / immunities rained down, / Tossed freely around like candy at a 4th of July parade
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Read more: Using Legal Preparedness to Minimize Liability Barriers to Accessing Pandemic Vaccine and Medical Countermeasures Using Legal Preparedness to Minimize Liability Barriers to Accessing Pandemic Vaccine and Medical Countermeasures
Inefficiencies in negotiating vaccine procurement agreements during COVID-19 could have been attenuated with greater legal preparedness.
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Read more: Everything You Wanted to Know About Expanded Access but Were Afraid to Ask, Part 2 Everything You Wanted to Know About Expanded Access but Were Afraid to Ask, Part 2
In some cases there may be value in collecting “real world data” from Expanded Access.
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Read more: We All Stand to Benefit from Biden’s $2 Billion Bet on the Bioeconomy We All Stand to Benefit from Biden’s $2 Billion Bet on the Bioeconomy
Biden’s new initiative takes an expansive view of the roles of biotechnology and biomanufacturing in the United States economy.
