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2 Oct 2023, 8:26 pm by Kurt R. Karst
In the December 2019 Guidance, FDA writes that the clinical context for a disease (i.e., its rarity, its seriousness or life-threatening nature, and its unmet medical need) inform how much uncertainty the FDA will accept in terms of what constitutes an adequate and well-controlled trial (see Section V of that guidance available here). [read post]
18 Mar 2021, 10:28 am by Richard Hunt
That left the state law claims in the wrong court, so the case was remanded to the state court. [read post]
FOOTNOTES [1] Jennifer Tsai, Force Majeure Provisions in Chinese Contracts, Kira, 2-3 (February 2020), https://kirasystems.com/files/guides-studies/KiraSystems-Deal_Points_Force_Majeure_Coronavirus.pdf.[2] Reade v. [read post]
3 Jan 2007, 6:59 am
  In Part V, I talked about the legal framework of foreign service businesses in China. [read post]
14 Aug 2013, 9:22 pm by Glotzer & Sweat
 It states that, “a person riding a bicycle … has all the rights … and is subject to all the provisions applicable to the driver of a vehicle. [read post]
17 Jul 2009, 5:21 am
You can separately subscribe to the IP Think Tank Global Week in Review at the Subscribe page: [duncanbucknell.com]   Highlights this week included: ECJ rules that printing isn’t transient: Infopaq International A/S v Danske Dagblades Forening (1709 Copyright Blog) (IPKat) UK National Portrait Gallery threatens Wikipedia user over public domain images (Creative Commons) (1709 Copyright Blog) (Excess Copyright) (1709 Copyright Blog) (IPKat) New Zealand releases… [read post]
2 Jul 2007, 3:37 pm
* Another great study from Jim Jansen (see the last one I blogged about). [read post]
12 Jun 2022, 6:30 am by Guest Blogger
Thus, for those frustrated with (or openly hostile to) particular elements of the Constitution, such as Article V, brevity has provided a path forward. [read post]
3 Oct 2018, 12:50 pm by Adam Feldman
Although there was a drop off in such cases for the 2017 term, the court heard several salient patent cases last term as well, with Oil States Energy Services v. [read post]
23 Dec 2011, 6:30 am by Sarah Tran
Trask (Jones Day); An Empirical Study of the Effect of KSR v. [read post]
21 Feb 2019, 4:00 am by Administrator
”[72] Justice L’Heureux-Dubé, however, did not agree that an expression stated in the positive (i.e., a “significant contributing cause”) meant the same thing as one stated in the negative (i.e., “not a trivial cause”). [read post]
26 Sep 2010, 10:08 pm by Marie Louise
(Patently-O) US Copyright – Decisions Breaking news: Lara Jade Coton awarded $130,000 in damages (Plagiarism Today) Ohio record pirating statute pre-empted by Copyright Act: State v. [read post]
23 Feb 2016, 4:31 pm by Kevin LaCroix
” Frankfurter’s dissents are today studied “if at all, only for their futility. [read post]