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10 Sep 2023, 7:24 pm by Kurt R. Karst
  The final guidance contains a new addition that states that if there is an appropriate justification as to why a sponsor cannot submit patient-level data to FDA through traditional channels, third parties can provide these data through either a pre-IND or Type V Drug Master File (“DMF”) and provide the sponsor with a letter of authorization for FDA to reference the data. [read post]
10 Sep 2023, 4:00 am by SHG
Samford University; and Judge Kim Wardlaw, a very liberal Clinton nominee, eviscerated Arizona State’s lawyer during oral argument for the pathbreaking decision, Schwake v. [read post]
5 Sep 2023, 7:13 am by Eugene Volokh
United States (1908) and Indian trust doctrine under United States v. [read post]
3 Sep 2023, 4:43 pm by INFORRM
On 4 August 2023, the Court of Appeal handed down judgment in National Council for Civil Liberties, R (On the Application Of) v Secretary of State for the Home Department & Anor [2023] EWCA Civ 926. [read post]
1 Sep 2023, 10:59 am by Edward T. Kang
Rule 408 Precludes Some Settlement Evidence From Being Admitted The Federal Rule of Evidence 408 is the model for many state court rules. [read post]
23 Aug 2023, 7:45 pm
Richard and Mary Eshelman Faculty Scholar; Professor of Law and International Affairs; Pennsylvania State University | 239 Lewis Katz Building, University Park, PA 16802 1.814.863.3640 (direct) || lcb11@psu.edu First I want to thank Marcelo Thompson, Han Zhu, and Dean Fu Hualing, and all those who organized this workshop. [read post]
22 Aug 2023, 9:00 pm by Sherica Celine
Practical Guidance Diversity, Equity, and Inclusion Related Content Corporations across the United States are evaluating how they manage diversity, equity and inclusion (DEI) policies in the workplace in light of the recent Supreme Court decision striking down affirmative action policies on the basis of race in education, ( Students for Fair Admissions, Inc. v. [read post]