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23 Apr 2024, 1:58 am
The European Medicines Agency (EMA) expected guidance is welcome EFPA welcomes the EMA’s efforts to assess the impact of AI in R&D, such as in its consultation on a draft reflection paper and multi-annual work plan, and its emphasis on a “risk-based” approach. [read post]
5 Apr 2024, 10:57 am
Despite the DCP’s acknowledgment that the booster caused Shepherd’s pericarditis, they denied liability, attributing the mandate to a lawful State Government Public Health Order (PHO) under the Emergency Management Act 2004 (EMA). [read post]
7 Mar 2024, 12:40 am
Yangi foydalanuvchilarni ro’yxatdan o’tkazish uchun innovatsion yondashmalarni izlash – istisno emas. [read post]
27 Feb 2024, 11:17 am
EMA, the court also validates children’s speech rights because “laws that require parental consent for children to access constitutionally protected, non-obscene content, are subject to strict scrutiny. [read post]
21 Feb 2024, 9:01 pm
Impact of cutting antibiotic usage on farmsECDC, EFSA, and EMA analyzed trends of antimicrobial consumption and AMR in E. coli from humans and food-producing animals. [read post]
27 Dec 2023, 9:01 pm
“The FDA has extensive experience with economically motivated adulteration (EMA) that constitutes a fraud on consumers across a broad array of regulated products,” explained Haddow. [read post]
29 Aug 2023, 9:46 am
Suit identified ED nurses, the hospital, a first-year resident and the attending doctor, as well as the attending doctor’s group practice, EMA. [read post]
26 Jul 2023, 9:00 am
A recent decision has expanded the scope of cost-recovery actions for contaminated sites under the Environmental Management Act, SBC 2003, c.3 (the EMA). [read post]
18 Jul 2023, 11:45 am
The EMA’s investigation centers on medicines that contain either semaglutide or liraglutide. [read post]
3 Jul 2023, 12:41 am
Northern Ireland would thus be reintegrated back into a UK-only regulatory environment, with the European Medicines Agency (EMA) being removed from having any role. [read post]
12 May 2023, 10:59 am
EMA, the Court ruled that while the State might have “the power to enforce parental prohibitions—to require, for example, that the promoters of a rock concert exclude those minors whose parents have advised the promoters that their children are forbidden to attend, . . . it does not follow that the state has the power to prevent children from hearing or saying anything without their parents' prior consent” (564 U.S. 786, 795 n.3). [read post]
27 Apr 2023, 12:12 pm
In the case of medicinal products, unitary SPCs will only be allowed on the basis of centralized marketing authorizations issued by the European Medicines Agency (EMA). [read post]
7 Mar 2023, 3:44 am
An EMA centralised approval thus no longer covers the UK. [read post]
23 Jan 2023, 4:13 am
[Section 2(d) refusal of OPTCONNECT EMA, OPTCONNECT, and OPTCONNECT MANAGED WIRELESS SOLUTIONS and design for goods and services used to connect devices to the internet of things, in view of the registered mark OPCONNECT for "interactive computer kiosks comprising computers, computer hardware, computer peripherals, and computer operating software, for use in digital advertising and electric vehicle charging. [read post]
30 Dec 2022, 4:03 am
January 10, 2023 - 1 PM: In re OptConnect Management, LLC, Serial Nos. 88458653 and 88458583 [Section 2(d) refusals to register OPTCONNECT and OPTCONNECT EMA for modems, network routers, and other networking devices designed to facilitate machine-to-machine communications, and for related software and services, in view of the registered mark OPCONNECT for "Interactive computer kiosks comprising computers, computer hardware, computer peripherals, and computer operating software, for use… [read post]
7 Dec 2022, 6:13 pm
However, while announcing in November 2020 that this endpoint was achieved, the sponsor shared that “[b]ased on interactions with the FDA and EMA,” it changed this primary endpoint for the trial to the co-primary endpoints of FIX activity and annualized bleeding rate (“ABR”), now measured at 52 weeks. [read post]
7 Dec 2022, 8:51 am
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20 Nov 2022, 11:22 am
The EMA system is a roll of the dice for both sides. [read post]
18 Nov 2022, 6:50 am
Six years ago Dell Technologies financed its multi-billion dollar acquisition of EMC Technologies by issuing a special class of “V” shares. [read post]
14 Nov 2022, 2:55 am
In particular, what is of interest to patent practitioners is that from the beginning of next year, all applications submitted to the EMA for the conduct of clinical trials will be published in a publicly available portal as soon as the application is allowed by the EMA. [read post]
