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22 Apr 2018, 9:00 am by Michael H Cohen
Class III devices generally require premarket market approval (PMA), while a Class I or Class II device, is not exempt, requires clearance of a premarket notification (510(k)), which means that a “predicate device” is already being legally marketed and FDA deems that the predicate is “substantially equivalent” to the device in question. [read post]
20 Apr 2018, 6:27 pm by Dan Flynn
 He says romaine production out of California is not associated with the outbreak. [read post]
18 Apr 2018, 10:59 am by Wenqing Zhao, David Stanton
On April 5, President Trump directed the trade representative to consider levying a second wave of tariffs against an additional $100 billion in Chinese goods, again under Section 301. [read post]
18 Apr 2018, 4:00 am by Louis Mirando
The first county law library in Ontario dates to 1854 with the founding of the Brant County Law Association. [read post]
17 Apr 2018, 5:50 pm by Brian Orion
These were generally supportive of the overall direction of the Order, and asked for clarifications related to applicability in their specific markets and their role in implementation when there could be overlap with state authority. [read post]
17 Apr 2018, 3:05 pm by Mark Walsh
” Kennedy, who had invited the challenge to Quill with his concurrence in 2015’s Direct Marketing Association v. [read post]
17 Apr 2018, 6:12 am by Bruce E. Boyden
Most often it is associated with the course taught by Henry Hart and Albert Sacks, and with its strong criticism of the Warren Court in a series of articles and lectures at Harvard. [read post]
17 Apr 2018, 5:00 am by John Jascob
Paul Cellupica, deputy director of Investment Management, directed seminar attendees’ attention to the Commission’s upcoming Open Meeting on Wednesday, April 18. [read post]
16 Apr 2018, 11:54 am by Kelsey Farish
The Court of Appeals for the Fourth Circuit later threw out the $25 million piracy liability verdict.EU-ser Created Content: draft Copyright Directive fails to hit the right note with artistsAbout 18 months ago, the European Commission announced its proposal for a Directive on Copyright in the Digital Single Market, currently in draft stages  Industry groups are keen to ensure their opinions are taken into consideration, especially in instances where consumers… [read post]
16 Apr 2018, 3:00 am by William Ford
Employment Announcements (More details on the Job Board) Associate General Counsel, Office of the Director of National Intelligence Summary Position Information This is an opportunity for: An internal or external candidate to fill a GS-15 cadre position. [read post]
13 Apr 2018, 1:59 pm by Kelly Phillips Erb
You can’t typically deduct annual expenses associated with making your house more of a home, but there is a bright side: Some items that are not deductible as an expense may increase your basis. [read post]
13 Apr 2018, 10:30 am by Harry Larson, Sabrina McCubbin
Prosecutors first indicted Stevens, the former vice president and associate general counsel of pharmaceutical company GlaxoSmithKline, in November 2010, charging her with obstructing a proceeding and falsifying and concealing documents in connection with an FDA inquiry into whether GlaxoSmithKline had illegally marketed certain drugs for off-label use. [read post]
13 Apr 2018, 8:58 am by Rebecca Tushnet
  Kellogg—SCt contemplated remedy directed not at name or shape but packaging, but here Kellogg had adequately distinguished its products. [read post]
13 Apr 2018, 7:00 am by Ken Kieklak
Advertising or marketing defects: This type of defect refers to the failure to properly advertise or otherwise warn about the proper use, handling, and possible dangers associated with the use of a product. [read post]
12 Apr 2018, 7:42 pm by Cynthia Marcotte Stamer
  Among other things, the FLSA tipped employee rules generally provide that a restaurant employer may consider tips part of wages (“tip credit”) provided by the employer only if it meets specific requirements including: The employer must pay the tipped employee at least $2.13 an hour in direct wages; The employer must ensure that the additional amount of tips a tipped employee receive coupled with the employee’s direct wages equals or exceeds the minimum… [read post]
12 Apr 2018, 12:14 pm by Tim Hewson
So the family scrambles through important papers, trying to get some direction on what to do next. [read post]