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6 Mar 2024, 1:11 am by David Pocklington
Luke Blackburn [2024] ECC Bla 3] [Top of section] [Top of post]. [read post]
2 Oct 2023, 8:26 pm by Kurt R. Karst
This has coincided with a similar increase in FDA review divisions citing to, analyzing, and applying this authority during their review of and, ultimately, approval of recent NDAs and BLAs. [read post]
15 Aug 2023, 12:50 am by David Pocklington
If it meant only that it would be pointless to state it. [read post]
11 Jul 2023, 2:17 pm by Kurt R. Karst
  And, like it has before, the District Court of D.C. recently grappled with this very question in Ipsen v. [read post]
9 May 2023, 1:52 am by David Pocklington
George the Martyr Preston [4], in which Hodge Ch. stated: “[29]. [read post]
2 May 2023, 12:30 am by David Pocklington
George the Martyr Preston [2023] ECC Bla 2 Extensive reordering works were proposed. [read post]
8 Dec 2022, 6:06 am by Chile Eboe-Osuji
(See Prosecutor v Blaškić (Judgement on the Request of the Republic of Croatia for Review of the Decision of Trial Chamber II of 18 July 1997) 27 October 1997 (ICTY Appeals Chamber), para 38.) [read post]
15 Nov 2022, 2:17 am by Kurt R. Karst
Download either Form FDA 3602 (for a business headquartered in the United States) or Form FDA 3602A (for a business headquartered outside the United States). [read post]
27 Oct 2022, 7:59 pm by Kurt R. Karst
FDA added examples in Section V of the guidance of modifications to an approved CP that must be submitted as an annual report. [read post]
2 Sep 2022, 12:30 am by David Pocklington
In reviewing the legal principles which apply in disposal cases, it stated: “[51]. [read post]
21 Aug 2022, 12:35 am by Frank Cranmer
And finally…II Per Julian Knowles J in Al-Masarir v Kingdom of Saudi Arabia [2022] EWHC 2199 (QB) at [195]: “There are shades of Mandy Rice-Davies in this explanation — ‘they would say that, wouldn’t they? [read post]
14 Aug 2022, 1:26 am by Frank Cranmer
Church and State On Friday, the House of Commons Library published a research briefing on The relationship between church and state in the United Kingdom written by David Torrance. [read post]
14 Apr 2022, 7:37 pm by Kurt R. Karst
  The draft MDUFA V commitment letter states that FDA plans to transition the pilot program to a “sustainable and expanded program” by the end of FY 2023, incorporating lessons learned from the pilot program. [read post]