Search for: "In Interest of BLA"
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28 Apr 2015, 9:14 am
Congress carefully balanced the interests between sponsors and applicants, determined what the consequences should be at each step of the process for not completing it, and allowed the parties to weigh the benefits of proceeding against the consequences of not. [read post]
31 Dec 2023, 5:25 am
The Deputy Chancellor determined that three of the objectors had a sufficient interest. [read post]
30 Apr 2023, 8:00 pm
Taken together, these aspects of the proposed legislation are likely to prevent potential litigants—including brands, generics, public-interest groups, and interested members of the public—from vindicating their rights or protecting their interests in multiple contexts, and ultimately poses a clear and direct threat to the public health by immunizing critical safety-related issues from timely judicial review. [read post]
12 Sep 2022, 3:04 pm
Which I think is is is an interesting development, because I know a lot of the law school people we see fresh out of law school, are not conversant with what’s going to be expected of them when they hit the law firm. [read post]
28 Dec 2011, 1:04 am
As the well-worn proverb has it: interesting times lie ahead for human rights law. [read post]
8 Aug 2012, 8:40 pm
Among other things, Octapharma claimed that the company has “a Constituionally-protected interest” in the orphan drug exclusivity FDA granted for WILATE, and that FDA may not rescind exclusivity without providing the company an opportunity to defend its exclusivity interest at a formal hearing. [read post]
2 May 2023, 12:30 am
George the Martyr Preston [2023] ECC Bla 2 Extensive reordering works were proposed. [read post]
25 Jan 2021, 10:51 am
For the Balkinization Symposium on Alexander Keyssar, Why Do We Still Have the Electoral College? [read post]
13 Feb 2020, 6:43 pm
That leaves open an interesting question: whether the leverage obligations under international law may take precedence over the prudential obligation of business to prevent, mitigate or remediate legal risk (including the risk of veil piercing or of agency). [read post]
16 Apr 2022, 6:30 am
But Eugene’s attitude about foreign interference is almost blasé. [read post]
2 Oct 2023, 8:26 pm
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]
10 May 2024, 1:33 am
Barnabas Morecambe [2023] ECC Bla 3] Re St. [read post]
19 Jun 2019, 3:02 am
But as a legal blogger I'm between two worlds - allowed in because of me lawyer credentials, and yet not really a journalist who can hide behind the public interest (or editorial demands). [read post]
5 Sep 2006, 6:11 pm
Mesic, the Croatian President, testified in the case against former Croatian Army general Tihomir Blaškic. [read post]
10 Jun 2016, 4:00 am
It’s because it involves a woman, and violates the feminist self-interest, that women are special, and therefore crimes against women are special. [read post]
29 Nov 2010, 11:01 am
I become blasé and then even demanding. [read post]
9 Dec 2021, 2:56 pm
Introduction I often explain the difference between (non-lienable) maintenance and repair work on the one hand and (lienable) construction work on the other, by using the analogy of the landscaper who may be called to a worksite and, in one scenario, asked to mow the grass and trim the hedges or, in another scenario, to terra-form an entire property, complete with a new deck, sheds, a koi-pond and stone pathway. [read post]
5 Oct 2006, 12:23 am
The Trial Chamber ruled that "it is in the interest of justice to conduct a site visit to locations of crimes alleged in the Indictment". [read post]
13 Mar 2024, 7:24 pm
Namely, Genmab A/S must demonstrate its agency relationship with the BLA holder (Genmab US, Inc.) as it relates to the approved product and provide evidence of its express authorization to rely upon the regulatory activities by Genmab US, Inc. [read post]
10 Jul 2014, 10:34 pm
Not only is that what All Saints Waccamaw decided; but consistent with that decision, the Diocese subsequently gave each parish a quitclaim deed renouncing any remaining interest in its parishes' property. [read post]
