David A. Simon
@davidasimon.bsky.social
7.9K followers 780 following 48 posts
Associate Professor, Northeastern University School of Law www.davidasimon.us Co-Director, Amy J. Reed Collaborative for Medical Device Safety https://www.safemedicaldevices.org/ Researcher, the CLASSICA Project https://classicaproject.eu/team/
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davidasimon.bsky.social
There’s a provision of the FDCA that covers counterfeiting!
davidasimon.bsky.social
I just wondered if they have to approve submissions or how that works
davidasimon.bsky.social
Can someone explain how ssrn e-journals work? Like why is my paper not included for several days? Is there someone curating them?
Reposted by David A. Simon
davidasimon.bsky.social
vanda makes two claims:

1. that the FDA regulations interpreting misbranding are uncon; and
2. FDA guidance documents on off-label communications are uncon.

Given Loper Bright, 1 at least one has some potential, but 2 are likely to fail, given that guidance documents are not challengeable.
davidasimon.bsky.social
in april, Vanda Pharm sued the FDA over its new guidance on off-label promotion. this underscores the need for a better system, like the one I proposed several years ago--at the very least a better disclosure document. compare industry to my approach (mine is one page but LR margins too wide)
davidasimon.bsky.social
I suspect it’s a variety of things. One is the way we are trained. A second is the student component. A third is that criticisms of a paper often hinge on failure to discuss or explain something.
davidasimon.bsky.social
I don’t see a no in there.
Reposted by David A. Simon
sharonbrett.bsky.social
Call for Papers for 15th Annual Fed Courts Junior Scholars conference is now up: law.ku.edu/junior-facul.... Lots of advanced notice, hope you will consider submitting!

Will work on distributing this to various listservs and blogs, but please share if you are able.
15th Annual Junior Faculty Federal Courts Workshop
April 24, 2026| KU School of Law
law.ku.edu
Reposted by David A. Simon
davidasimon.bsky.social
Just posted my paper, Off-Label Inducement, to SSRN. It argues for a new (old) tort to hold drug and device manufacturers liable for inducing clinicians to make unsafe off-label uses.

papers.ssrn.com/sol3/papers....
davidasimon.bsky.social
curious if you mean structural reforms re organization of the government or structural reforms re: economic system
davidasimon.bsky.social
First day back in the classroom and it was a joy 🙌
davidasimon.bsky.social
Underappreciated legal movie: the blues brothers. A film about the property tax system in cook county.
davidasimon.bsky.social
I am updating my list of law conferences. Please DM if you want to add one. I typically focus on:

1. Health
2. IP
3. General Law
4. Law & Philosophy

www.davidasimon.us/conferences
Conferences | David A. Simon
www.davidasimon.us
davidasimon.bsky.social
Another beautiful day in one of the greatest cities in the world
davidasimon.bsky.social
Just posted my paper, Off-Label Inducement, to SSRN. It argues for a new (old) tort to hold drug and device manufacturers liable for inducing clinicians to make unsafe off-label uses.

papers.ssrn.com/sol3/papers....