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19 Sep 2023, 10:30 pm by Tomasz Tadeusz Koncewicz
And finally, in the most recent C-204/21 Commission v Poland, the Court asserted its authority in the strongest possible terms by proclaiming that, “the review of Member States’ compliance with the requirements arising from Article 2[…] TEU falls fully within the jurisdiction of the Court” (para. 62), and that Article 2 TEU is not merely a statement of policy guidelines or intentions, but rather “contains values which are an integral part of the… [read post]
15 Sep 2023, 10:26 am by Daniel J. Gilman
Here’s the Wall Street Journal under the demure title, “U.S. v. [read post]
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]