Artificial Intelligence & Machine Learning: Recent Scholarship
Objective Intent Blog
by Erika Lietzan
1y ago
As FDA has noted, artificial intelligence (AI) and machine learning (ML) technologies have the potential to transform healthcare. These technologies could be used at the agency, by other agencies involved in healthcare regulation and finance, by private participants in the healthcare delivery system, and by medical device manufacturers. They can also be embedded in conventional medical devices or, indeed, serve as standalone medical devices. For several years now, FDA has been exploring how its existing medical device framework applies, or should be adapted to apply to, software ..read more
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Recent Scholarship: FDA and Other Regulators
Objective Intent Blog
by Erika Lietzan
1y ago
As readers know, FDA does not operate in a vaccuum; it has relationships with, and sometimes collaborates with, other federal regulators. It shares information with them, it may receive information from them, and sometimes it shares jurisdiction with another agency or shares responsibility for implementing a particular program. (For instance, both PTO and FDA play a role in implementing the patent term restoration provisions of section 156 of the Patent Act. Some of my work explores the FDA/PTO intersection.) Today I highlight two recent pieces of scholarship focusing on FDA and other regulato ..read more
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The Tradeoffs Involved in New Drug Approval, Expanded Access, and Right to Try
Objective Intent Blog
by Erika Lietzan
1y ago
This note explains some of the concepts swirling around in the media right now, relating to medicine approval. Much of what follows appears (or will appear) in an article on the U.S. “right to try” law, which I recently wrote with a colleague at the University of Bourgogne in Dijon, France.  Some of the background discussion will be useful here. Premarket Approval A new medicine must be approved by FDA before it can be shipped in interstate commerce (effectively, before it can be sold commercially for use by patients).  There are two pathways to market in the United States: a biologi ..read more
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Vaccine Approval 101
Objective Intent Blog
by Erika Lietzan
1y ago
Here’s a tutorial on the usual process for vaccine development, testing and approval, for folks tracking the new coronavirus (COVID-19).  In brief: it will take a while and very large clinical trials to get a coronavirus vaccine approved at FDA. But preapproval testing is likely to happen on the ground where the coronavirus is spreading, and there is a potential for expanded access (to the unapproved vaccine) in the meantime. Vaccines Need Preapproval Vaccines are intended to prevent disease.  As a result they are considered “drugs” under the Federal Food, Drug, and Cosmetic Act as w ..read more
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SSRN Reading List . . . or Device Regulation: What Role for Tort Law?
Objective Intent Blog
by Erika Lietzan
1y ago
The 2020 annual conference of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics (at Harvard Law School) will focus on the future of medical device regulation.  If you’re interested in participating, abstracts are due on October 14, final papers are due March 27, and the conference is May 8.  (Here’s a link to the call for papers.)  I’m working on an empirical project relating to device premarket approval and patent term restoration, but sadly the dataset won’t be ready in time.  Meanwhile, here’s a run-down of some interesting legal scholarship on m ..read more
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FDA’s Abandoned Proposal to Require Reporting of Data Falsification
Objective Intent Blog
by Erika Lietzan
1y ago
On August 6, FDA announced that Novartis’s application for approval of Zolgensma contained “manipulated” data and that the company knew this while the application was pending, but did not tell the agency.  Three days later a group of Senators wrote FDA a letter asking, among other things, why the agency had withdrawn a proposed regulation that would have required “sponsors of certain clinical trials to promptly report suspected data falsification to FDA.”  It may be helpful to review the concerns that people raised.  Details after the jump. The Proposal (here) FDA proposed to am ..read more
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The Big “Data Manipulation” Story
Objective Intent Blog
by Erika Lietzan
1y ago
One of the big end-of-summer news stories at FDA is the agency’s August 6 statement that Novartis submitted “manipulated” data to support approval of its gene therapy product, Zolgensma.  According to FDA, Novartis knew about the manipulation before FDA approved the product, and yet the company didn’t disclose the manipulation to the agency until June 28 — more than a month after approval.  A group of Senators (including Presidential hopefuls…) has said the company’s “greed” cannot be condoned and that FDA should hold the company accountable for its “malfeasance.”  They have als ..read more
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