Open Access. Powered by Scholars. Published by Universities.®
- Keyword
-
- Administrative Law (2)
- Death (2)
- Food and Drug Law (2)
- Health Law and Policy (2)
- Health law (2)
-
- Hospice (2)
- Medical Jurisprudence (2)
- Palliative care (2)
- Science and Technology (2)
- Terminal illness (2)
- Articles (1)
- Bioethics (1)
- Biologics (1)
- DNA (1)
- End of life (1)
- End-of-life (1)
- Food and Drug Administration (1)
- Food and drug law (1)
- Generic Drug (1)
- Hatch-Waxman (1)
- Human subject protections (1)
- Law and Technology (1)
- Science (1)
- Technology (1)
- Publication
Articles 1 - 3 of 3
Full-Text Articles in Law
Throwing Dirt On Doctor Frankenstein's Grave: Accesss To Experimental Treatments At The End Of Life, Michael J. Malinowski
Throwing Dirt On Doctor Frankenstein's Grave: Accesss To Experimental Treatments At The End Of Life, Michael J. Malinowski
Michael J. Malinowski
Abstract
All U.S. federal research funding triggers regulations to protect human subjects known as the Common Rule, a collaborative government effort that spans seventeen federal agencies. The Department of Health and Human Services has been in the process of re-evaluating the Common Rule comprehensively after decades of application and in response to the jolting advancement of biopharmaceutical science. The Common Rule designates specific groups as “vulnerable populations”—pregnant women, fetuses, children, prisoners, and those with serious mental comprehension challenges—and imposes heightened protections of them. This article addresses a question at the cornerstone of regulations to protect human subjects as biopharmaceutical research …
Throwing Dirt On Doctor Frankenstein’S Grave: Access To Experimental Treatments At The End Of Life, Michael J. Malinowski
Throwing Dirt On Doctor Frankenstein’S Grave: Access To Experimental Treatments At The End Of Life, Michael J. Malinowski
Michael J. Malinowski
All U.S. federal research funding triggers regulations to protect human subjects known as the Common Rule, a collaborative government effort that spans seventeen federal agencies. The Department of Health and Human Services has been in the process of re-evaluating the Common Rule comprehensively after decades of application and in response to the jolting advancement of biopharmaceutical science. The Common Rule designates specific groups as “vulnerable populations”—pregnant women, fetuses, children, prisoners, and those with serious mental comprehension challenges—and imposes heightened protections of them. This article addresses a question at the cornerstone of regulations to protect human subjects as biopharmaceutical research and …
The Illusion Of Interchangeability: The Benefits And Dangers Of Guidance-Plus Rulemaking In The Fda's Biosimilar Approval Process, Jonathan Stroud
The Illusion Of Interchangeability: The Benefits And Dangers Of Guidance-Plus Rulemaking In The Fda's Biosimilar Approval Process, Jonathan Stroud
Jonathan R. K. Stroud
On March 23, 2010, President Obama signed into law the ambitious Patient Protection and Affordable Care Act. While media attention focused largely on the sweeping changes the bill makes to the nation’s healthcare system, there was also a less-noticed rider to the bill, the Biologics Price Competition and Innovation Act of 2009 (Biosimilars Act). The Biosimilars Act grants the Food and Drug Administration (FDA) broad new authority to create an accelerated premarket approval pathway for generic competition to biologics in an attempt to drive biologic drug prices down and reduce the overall costs of health care. Traditionally, inventors of medical …