Human Subjects Research in Emergencies: The Texas Nursing Home “Study” (Part II)
Almost immediately, there was a public outcry about the possibility that this was an illegal or unethical “research experiment.”
Pharmaceuticals
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Read more: How Can the US Address Coronavirus Drug Shortages? How Can the US Address Coronavirus Drug Shortages?
With the sudden spike in hospitalized patients with COVID-19 symptoms, physicians are using these drugs faster than manufacturers are making them.
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Read more: Highlights from FDA Meetings on 3 Opioid-Related New Drug Applications Highlights from FDA Meetings on 3 Opioid-Related New Drug Applications
In January 2020, two FDA committees met to consider approval of three opioid-related new drug applications.
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Read more: What Does It Mean That Oracle is Partnering with the Trump Administration to Study Unproven COVID-19 Drugs? What Does It Mean That Oracle is Partnering with the Trump Administration to Study Unproven COVID-19 Drugs?
Cross-posted from Written Description, where it originally appeared on March 30, 2020. By Lisa Larrimore Ouellette, Nicholson Price, Rachel Sachs, and Jacob Sherkow One of the dizzying stream of innovation and health law stories to emerge last week is Oracle’s partnership with the White House to study unproven pharmaceuticals for treating COVID-19. We decided to unpack this story for ourselves and then…
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Read more: Seife v. HHS: A Decade of Missing Trial Data Seife v. HHS: A Decade of Missing Trial Data
By Phebe Hong Data is knowledge, and knowledge is power. Thanks to a recent court ruling, more medical data may soon be available to the public. A Southern District New York federal judge ruled this week that the FDA and NIH had been misinterpreting a law requiring clinical trial sponsors to release data. The ruling…
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Read more: A Local City Takes on Pharma A Local City Takes on Pharma
By Phebe Hong A city northwest of Atlanta is taking on Big Pharma. On February 6th, the city of Marietta filed a lawsuit in federal court in Atlanta against Mallinckrodt, a global specialty pharmaceutical company. The class action complaint alleges that Mallinckrodt is “unjustly enriched” by its “exorbitant and unconscionable prices” for Acthar, a therapeutic…
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Read more: Why Our Health Care Is Incomplete: Review of “Exposed” (Part II) Why Our Health Care Is Incomplete: Review of “Exposed” (Part II)
By: Daniel Aaron Just last month, Professor Christopher T. Robertson, at the University of Arizona College of Law, released his new book about health care, entitled Exposed: Why Our Health Insurance Is Incomplete and What Can Be Done About It. Part II of this book review offers an analytical discussion of “cost exposure,” the main…
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Read more: Why Our Health Care Is Incomplete: Review of “Exposed” (Part I) Why Our Health Care Is Incomplete: Review of “Exposed” (Part I)
By Daniel Aaron Just last month, Professor Christopher T. Robertson, at the University of Arizona College of Law, released his new book about health care, entitled Exposed: Why Our Health Insurance Is Incomplete and What Can Be Done About It. This book review will offer an analytical discussion of “cost exposure,” the main subject of…
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Read more: The Rise of Biosimilars: Success of the BPCIA? (Part III) The Rise of Biosimilars: Success of the BPCIA? (Part III)
By Jonathan Darrow This is Part III in a series exploring the history, challenges, and opportunities in the regulation of biosimilars, or biologic medical products that are very similar to already approved biological medicines. Part III considers a path forward in the regulation of biologics. For Part I, click here. For Part II click here.…
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Read more: The Rise of Biosimilars: Success of the BPCIA? (Part II) The Rise of Biosimilars: Success of the BPCIA? (Part II)
By Jonathan Darrow This is Part II in a series exploring the history, challenges, and opportunities in the regulation of biosimilars, or biologic medical products that are very similar to already approved biological medicines. Part II covers some key considerations and factors that impact the biologics market and regulation. For Part I, click here. Reference…