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Medicine and Health Sciences Commons

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Health Law and Policy

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Full-Text Articles in Medicine and Health Sciences

The Big Data Regulator, Rebooted: Why And How The Fda Can And Should Disclose Confidential Data On Prescription Drugs And Vaccines, Christopher J. Morten, Amy Kapczynski Jan 2021

The Big Data Regulator, Rebooted: Why And How The Fda Can And Should Disclose Confidential Data On Prescription Drugs And Vaccines, Christopher J. Morten, Amy Kapczynski

Faculty Scholarship

Medicines and vaccines are complex products, and it is often extraordinarily difficult to know whether they help or hurt. The Food and Drug Administration (FDA) holds an enormous reservoir of data that sheds light on that precise question, yet currently releases only a trickle to researchers, doctors, and patients. Recent examples show that data secrecy can be deadly, and existing laws such as the Freedom of Information Act (FOIA) cannot solve the problem. We present here a wealth of new evidence about the urgency of the problem and argue that the FDA must “reboot” its rules to proactively disclose all …


Colloquium - Gender, Law And Health Care: New Perspectives For Teaching And Scholarship: The Role Of Gender In Law And Health Care, Karen H. Rothenberg Sep 1995

Colloquium - Gender, Law And Health Care: New Perspectives For Teaching And Scholarship: The Role Of Gender In Law And Health Care, Karen H. Rothenberg

Faculty Scholarship

No abstract provided.