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When Worlds Collide: The Theory of Real-World Evidence Meets Reality
13 May 2024, 5:58 pm by Kurt R. Karst
  Based on a review of premarket submissions made in 2012 through 2019, FDA identified 90 examples of 510(k)s, De Novos, HDEs, and PMAs approved/cleared which utilized RWE in support of regulatory decision-making. [read post]
FDA Law Blog - https://www.thefdalawblog.com/
U.S. Supreme Court, Macquarie Infrastructure Corp. v. Moab Partners, L.P., Docket No. 22-1165
13 May 2024, 3:42 pm
Separately, Item 303 of SEC Regulation S–K requires companies to disclose certain information in periodic filings with the SEC. [read post]
Frederic Borel - http://fredericborel.blogspot.ch/
Should Companies Announce Reviews of Strategic Alternatives?
12 May 2024, 9:05 pm by renholding
  ENDNOTE [1] Basic v. [read post]
The CLS Blue Sky Blog - https://clsbluesky.law.columbia.edu/
Discovery, certiorari, mandamus, foreign subpoena, and buckwheat crepes with prosciutto, arugula, and asiago
12 May 2024, 1:42 pm by Law Lady
CALIXTE and DOROTHY DROUILLARD a/k/a DOROTHY CALIXTE, Petitioners, v. [read post]
The Appellate Gourmet (c) - http://appellategourmetappealsinflorida.blogspot.com/
Supreme Court Affirms Availability of Back-Damages Under Copyright Discovery Rule
9 May 2024, 10:55 am by Dennis Crouch
The Court rejected the Second Circuit’s approach in Sohm v. [read post]
Patently-O - https://patentlyo.com
Challenging books available to students held in a public school's library [Decisions of the Commissioner of Education No. 18,402]
9 May 2024, 7:00 am by Public Employment Law Press
Johnson; (4) Jesus Land: A Memoir by Julia Scheeres; and (5) Red Hood by Elana K. [read post]
New York Public Personnel Law - https://publicpersonnellaw.blogspot.com/
Challenging books available to students held in a public school's library [Decisions of the Commissioner of Education No. 18,402]
9 May 2024, 7:00 am by Public Employment Law Press
Johnson; (4) Jesus Land: A Memoir by Julia Scheeres; and (5) Red Hood by Elana K. [read post]
New York Public Personnel Law - https://publicpersonnellaw.blogspot.com/
Plaintiffs in this action contend State and City policies deny Black and Latinx students their state constitutional right to a "sound basic education"
8 May 2024, 6:00 am by Public Employment Law Press
Coyle, Arthur Eisenberg, Rae Shih, Molly K. [read post]
New York Public Personnel Law - https://publicpersonnellaw.blogspot.com/
Plaintiffs in this action contend State and City policies deny Black and Latinx students their state constitutional right to a "sound basic education"
8 May 2024, 6:00 am by Public Employment Law Press
Coyle, Arthur Eisenberg, Rae Shih, Molly K. [read post]
New York Public Personnel Law - https://publicpersonnellaw.blogspot.com/
Games People Play: Before Hiring the Forensic Accountant
4 May 2024, 7:00 am by Mark Ashton
As we wrote recently in our analysis of Reich v. [read post]
Pennsylvania Family Law - http://pafamilylaw.foxrothschild.com/
The End* of a Long and Winding Road: FDA Publishes Final LDT Rule (*Or Is It?)
2 May 2024, 6:25 pm by Kurt R. Karst
See page 107 of FDA’s 1st Quarter FY2024 MDUVA V Report (here). [read post]
FDA Law Blog - https://www.thefdalawblog.com/
What constitutes LLC member or shareholder oppression in Illinois?
2 May 2024, 1:20 pm by Peter S. Lubin and Patrick Austermuehle
Paul K. [read post]
Chicago Business Litigation Lawyer Blog - http://www.chicagobusinesslitigationlawyerblog.com/
Maya Parizer et al. v. AJP Educational Foundation, Inc. a/k/a American Muslims for Palestine and National Students for Justice in Palestine Case 1:24-cv-00724 US District Court for the Eastern District of Virginia (Filed 05/01/24)
2 May 2024, 10:39 am
See also Boim v. [read post]
Law at the End of the Day - https://lcbackerblog.blogspot.com/
Publisher’s Platform: What you need to know about E. coli during an Outbreak
30 Apr 2024, 3:12 pm by Bill Marler
 E. coli O157:H7 is one of thousands of serotypes Escherichia coli.[1] The combination of letters and numbers in the name of the E. coli O157:H7 refers to the specific antigens (proteins which provoke an antibody response) found on the body and tail or flagellum[2] respectively and distinguish it from other types of E. coli.[3] Most serotypes of E. coli are harmless and live as normal flora in the intestines of healthy humans and… [read post]
Food Safety News - http://www.foodsafetynews.com/
Can a Public High School Punish a Student for Asking a Question that Refers to “Illegal Aliens”? Part Two in a Two-Part Series
29 Apr 2024, 9:01 pm by Vikram David Amar and Jason Mazzone
In Part One, we laid out the larger First Amendment framework in which the dispute might be located and discussed how the Court’s language and reasoning in Hazelwood School District v. [read post]
Verdict - http://verdict.justia.com/
[Eugene Volokh] Journalist Has No First Amendment Right to Publish Police Chief's Home Address,
29 Apr 2024, 5:04 pm by Eugene Volokh
Susan K. [read post]
The Volokh Conspiracy - http://www.volokh.com/
New Issue: American Journal of International Law
29 Apr 2024, 7:05 am by Jacob Katz Cogan
Colombia) Philipp Janig, X v. [read post]
International Law Reporter - https://ilreports.blogspot.com/
Can a Public High School Punish a Student for Asking a Question that Refers to “Illegal Aliens”? Part One in a Two-Part Series
28 Apr 2024, 9:01 pm by Vikram David Amar and Jason Mazzone
In 1969, in Tinker v. [read post]
Verdict - http://verdict.justia.com/
Week in Review
25 Apr 2024, 9:30 pm by The Regulatory Review
Supreme Court recognized the Boy Scouts of America’s First Amendment right to exclude gay men from membership—defining it as the right of “expressive association”—in the case Boy Scouts of America v. [read post]
RegBlog - https://www.theregreview.org/
Supreme Court Rules that MD&A Omission Does Not Give Rise to a Claim for Securities Fraud
25 Apr 2024, 1:28 pm by Hunton Andrews Kurth LLP
  Writing for a unanimous Court, Justice Sotomayor’s opinion nevertheless makes clear that “half-truths,” as distinguished from pure omissions, remain actionable under Item 303 of Regulation S-K. [read post]
Hunton Retail Law Resource Blog - https://www.huntonretailindustryblog.com/