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2 May 2024, 6:25 pm
Stage 4 November 6, 2027 High-risk LDTs requiring premarket approval (PMA) applications, humanitarian device exemption (HDE), or biologics license application (BLA) must comply with the PMA requirements To continue marketing after this date – applicable LDTs must be the subject of a PMA application, HDE, or BLA received by FDA, unless otherwise exempt Stage 5 May 6, 2028 Low and moderate-risk LDTs requiring premarket notification (510(k) notification) or de novo… [read post]
2 May 2024, 4:01 pm
Stuart K. [read post]
2 May 2024, 1:20 pm
Paul K. [read post]
2 May 2024, 11:57 am
To receive workers’ compensation wage loss benefits, also known as indemnity benefits (see, sections 440.13(2)&(4), Florida Statutes), the burden is on the injured worker (a/k/a, Claimant) to establish a connection between the work-related injuries and any wage loss. [read post]
2 May 2024, 10:39 am
AJP Educational Foundation, Inc. a/k/a American Muslims for Palestine and National Students for Justice in Palestine Case 1:24-cv-00724 US District Court for the Eastern District of Virginia (Filed 05/01/24). [read post]
2 May 2024, 9:54 am
New board chair-elect Directors elected Paul K. [read post]
2 May 2024, 6:19 am
Both the Palestinian protestors and pro Israel demonstrators at The University of Alabama are chanting “f**k Joe Biden” 😂😂😂pic.twitter.com/g2kYOk9m14— CJ Pearson (@thecjpearson) May 1, 2024 Meanwhile, yesterday in Freeland, Michigan: WOW!!! [read post]
1 May 2024, 9:05 pm
Last February, the European Council and the European Parliament reached a final compromise on an EU Listing Act.[1] The act aims to make listings in the EU – and raising capital through the stock market – more attractive by simplifying and harmonizing the listing rules. [read post]
1 May 2024, 2:56 pm
Innovation Park would also include a K-8 school, parks, businesses and 2,500 homes. [read post]
1 May 2024, 4:33 am
The protesters were screaming “F**k ICE” outside of the hall. [read post]
1 May 2024, 12:36 am
The New Yorker has posted an excellent essay ("How ECMO is Redefining Death") on the history, current status, and ethical challenges of extracorporeal membrane oxygenation (a/k/a ECMO), an out-of-body device that bypasses the heart and lungs by taking carbon dioxide out of a patient's blood, oxygenating it, and returning the blood to the patient's circulatory system. [read post]
30 Apr 2024, 3:12 pm
In addition to misclassification, other problem areas in construction that the WHD has identified include: not paying for all hours actually worked (including work done before or after the shift, as well as compensable downtime or meal breaks,) “banking” (a/k/a converting overtime hours into “comp time,” and failing to pay for travel from the shop to the work-site and back. [read post]
30 Apr 2024, 3:12 pm
Sources, Characteristics and Identification E. coli is an archetypal commensal bacterial species that lives in mammalian intestines. [read post]
30 Apr 2024, 12:44 pm
As a new partner in the Baltimore Library Project, Learning Undefeated will serve 10 K-8 schools this year, including the Maryland School for the Blind. [read post]
30 Apr 2024, 6:31 am
Posted by Benjamin Means (University of South Carolina) and Douglas K. [read post]
30 Apr 2024, 6:31 am
Posted by Benjamin Means (University of South Carolina) and Douglas K. [read post]
30 Apr 2024, 4:58 am
Attorney James K. [read post]
30 Apr 2024, 3:10 am
An HSA Future Value Calculator can help employees project the future value of their account, while an HSA and 401(k) Maximizer can help employees determine how the accounts can collectively support their savings goals. [read post]
29 Apr 2024, 10:00 pm
This guidance provides specific recommendations for all three classes of products—biologics approved under 351(a) of the Public Health Service Act (PHS Act), and biosimilar products and interchangeable biosimilar products approved under 351(k) of the PHS Act—with respect to meeting FDA’s general accuracy and truthful and non-misleading standards that are applied to advertising and promotion of prescription drug products generally. [read post]
29 Apr 2024, 10:00 pm
This guidance provides specific recommendations for all three classes of products—biologics approved under 351(a) of the Public Health Service Act (PHS Act), and biosimilar products and interchangeable biosimilar products approved under 351(k) of the PHS Act—with respect to meeting FDA’s general accuracy and truthful and non-misleading standards that are applied to advertising and promotion of prescription drug products generally. [read post]