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15 Apr 2020, 2:40 pm
(This op-ed was first published in Just Security on April 13, 2020.) [read post]
25 Oct 2010, 10:52 am
FDA has long been of the opinion that ANDA drug product formulation changes made in an amendment to a pending application (or a supplement to an approved application) require a new certification, but has never (to our knowledge) been challenged on the issue. [read post]
18 Jun 2019, 6:42 am
SUPPLEMENT: Law360 published an article about this case in which they quoted my comments about the importance of the High Court’s opinion. [read post]
29 Aug 2019, 10:33 am
Bank, Slip Opinion No. 2019-Ohio-3342. [read post]
14 May 2007, 3:42 pm
Kocol issued his decision Jan. 13, 2006. [read post]
13 Jan 2012, 8:54 am
On December 13, 2011, Mr. [read post]
13 Jan 2012, 8:54 am
On December 13, 2011, Mr. [read post]
20 Jul 2015, 9:07 am
Judge Pillard wrote the opinion; it was joined by Judges Rogers and Wilkins. [read post]
19 Jul 2007, 1:47 pm
Id. at *13. [read post]
29 Jun 2010, 9:00 pm
Does 1-9 (Columbus, Ohio)John Doe #1 Motion to Quash*John Doe #9 Motion to Dismiss Complaint, Vacate Order, Quash Subpoena*John Doe #9 Motion for Stay*John Doe #5 Motion to Dismiss Complaint, Vacate Order, Quash Subpoena*John Doe #5 Motion for Stay*November 29, 2007, Order Granting Stay of Subpoena*RIAA Opposition Memo*Defendants' Reply Memo*April 18, 2008, Order and Opinion of Magistrate Judge Mark R. [read post]
18 Aug 2015, 7:09 am
The only other evidence was from a DOL opinion letter that simply noted that conventions were not within the scope of the exemption. [read post]
22 Oct 2008, 9:32 pm
Id at *13-14. [read post]
19 Apr 2017, 2:33 pm
To what extent is the OBOR Framework an alternative to or supplement of TTP-TTIP? [read post]
6 Jun 2016, 4:20 pm
During his 13-years of detention, bin Attash has only been permitted to send a single, short recorded video statement to his family. [read post]
20 Nov 2012, 5:01 pm
The present Board agrees with the opinion expressed in decision J 5/80 as summarised in the above headlines. [read post]
24 Jun 2011, 3:25 pm
" Certiorari stage documents:Opinion below (10th Circuit)Petition for certiorariBrief in oppositionRespondents' supplemental briefPetitioner's supplemental briefAmicus brief of the National Congress of American IndiansPetitioner's replyCVSG Information:Invited: February 22, 2011Filed: May 27, 2011 (Deny) Title: City of New York v. [read post]
17 Jun 2014, 8:45 am
In our opinion, the government’s current brief goes to undue lengths to gloss over the 510k/PMA distinction. [read post]
3 Sep 2019, 11:00 pm
In this way, the prohibition is not the only tool in the box but supplements other approaches. [read post]
3 Mar 2024, 9:01 pm
In a February 20, 2024 memorandum opinion, Vice Chancellor J. [read post]
28 Jun 2007, 10:16 am
In our bizarre tort system, you get sued anyway.Hell, if I knew that, I wouldn't have bothered with the supplemental NDA, and left everything off-label. [read post]