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14 Nov 2022, 1:25 am by Kurt R. Karst
  If an entity does not pay the full facility fee in a timely manner (meaning within 20 days of the due date) FDA will include the name in a publicly available arrears list, and all OTC monograph drug products produced at that facility are misbranded. [read post]
13 Nov 2022, 4:49 pm by Natalie Kirby
Nationally, inspectors report a safety issue for every 1 in 5 trucks that is serious enough for an out-of-service order, and they also place 1 in 20 drivers out-of-service for breaking some rule or another. [read post]
13 Nov 2022, 1:34 am by Rose Hughes
"[T]he mere indication that the embodiment does not or no longer fall under the respective claim(s) is not sufficient in this regard". [read post]
12 Nov 2022, 10:45 am by Guest Author
On this account, legislative delegation to the executive creates a principal-agent relationship.[1] Courts conduct judicial review to ensure that the administration acts a proper agent, staying within the confines of its legislatively-granted authority. [read post]
11 Nov 2022, 11:21 am by Rebecca Tushnet
Pukke, --- F.4th ----, 2022 WL 16568278, No. 20-2215, No. 21-1454, No. 21-1520, No. 21-1521, No. 21-1591, No. 21-1592 (4th Cir. [read post]
10 Nov 2022, 9:43 am by Chip Merlin
The next question is: “Does the insurance claim amount have an impact on the 50% Rule finding? [read post]
10 Nov 2022, 9:23 am by Jennifer Danish
According to the Centers for Disease Control, more than 1 out of every 4 American adults live with some form of functional disability. [read post]
10 Nov 2022, 5:12 am by Asha Rangappa
[Editor’s Note: For a deeper dive into Rangappa’s thoughts on the FBI’s reaction to January 6th and the culture inside the Bureau, listen to her in conversation with former FBI Acting Director Andrew McCabe on the Just Security Podcast] Much attention has been paid to the troubling institutional culture among agents at the U.S. [read post]
Such remuneration is provided by paragraph 2 of Article 91 of the BPS, which does not indicate the way to calculate it. [read post]
9 Nov 2022, 4:30 am by Donald Dinnie
What this judgment does not do is determine whether or not the Covid-19 regulations operating up to mid-September 2020 constitute applicable vis major entitling the tenant to remission of rental. [read post]
8 Nov 2022, 8:56 pm by Kurt R. Karst
For whose manufacturers who do not intend to continue device distribution, FDA generally does not intend to request market removal of those devices distributed before the applicable EUA termination or guidance withdrawal date. [read post]
8 Nov 2022, 1:21 pm by Scott R. Flick and Elizabeth Craig
Note, however, that a station does not need to report an adverse finding that was disclosed to the FCC in the context of an earlier station application where it was subsequently found by the FCC to be not disqualifying. [read post]
8 Nov 2022, 12:08 pm by Matthew Dochnal
20% of small businesses fail in the first year according to the Bureau of Labor Statistics. [read post]