The state's highest court allowed some claims brought on behalf of relatives of victims of the 2012 mass shooting at Sandy Hook Elementary School to proceed against the firearms industry.

A Florida district's decision to put armed "school safety assistants" in its elementary schools puts the safety and well-being of its students at risk and oversteps existing state law, says a lawsuit, which could topple school security plans throughout the state.

The three board members, along with a resident, request that the court grant a restraining order and preliminary injunction against the state to reverse the takeover.

Former Dawson City Mayor Bill Kendrick has filed his defence against the town's encroachment violation lawsuit.

A group of volunteers have been providing emergency services to West Dawson residents during the periods of freeze up and break up, when there is no reliable access across the Yukon River to town.

Advocates say pay equity laws, while needed, often do not help the most vulnerable workers.

A Winnipeg business owner is suing a man she alleges swindled her out of ownership of two properties after promising financial help — the latest in a string of court proceedings against the man, whom a judge previously described as showing the signs of a "predator" who seeks out financially vulnerable clients.

A Syilx Okanagan woman has filed a lawsuit against church authorities and the Canadian government alleging she was physically and sexually abused as a child at a Catholic-run Vernon, B.C., school.

Oregon

One of the country's largest horticulture machine makers blazes new trails with 3D CAD software

The developer of an app dropped from the App Store in China has filed a lawsuit that challenges Apple's overall practices, as well as damages of $420,000.

Apple has consistently been bowing to pressures from China and dropping apps from the App Store in the region. In this case, it's claimed an app called Bodyreader was pulled by Apple over reasons the developer believes are inconsistent.

According to Bloomberg Beijing's intellectual property court has accepted a complaint from Bodyreader's developer. The publication describes this as an Epic Games-style lawsuit on account of its scope concerning Apple's overall practices on the App Store.


Continue Reading on AppleInsider | Discuss on our Forums

In the wake of the 'Janus' Supreme Court case, teachers' unions are facing more than a dozen legal challenges backed by right-leaning groups that could further dampen their membership numbers and finances.

Two high school softball coaches are immune from a student's privacy lawsuit because there was no clearly established law barring school officials from discussing a student's private matters with the student's parent.

An Illinois judge has dismissed the nation's first class-action lawsuit against a state high school association over its handling of concussions, ruling that it had made strides in that regard since the filing of the lawsuit.

A Los Angeles judge ruled that a teenage football player may proceed to trial against the national Pop Warner organization, four years after he suffered an on-field injury that left him a quadriplegic.

Special education advocates argue the push for liability protection is a veiled attempt to seek waivers from the Individuals with Disabilities Education Act, the nation's primary special education law.

Special education advocates argue the push for liability protection is a veiled attempt to seek waivers from the Individuals with Disabilities Education Act, the nation's primary special education law.

Penn State’s Center for Socially Responsible Artificial Intelligence (CSRAI) will host “Diagnose-a-thon,” a competition that aims to uncover the power and potential dangers of using generative AI for medical inquiries. The virtual event will take place Nov. 11-17 with top prizes of $1,000.  

Penn State researchers explain what election and campaign finance laws say about Kamala Harris becoming the presumed presidential nominee on the Democratic ticket.

In a bid to dodge a US lawsuit, Swiss chocolatier Lindt & Sprungli has scuppered its own claims about the excellence of its products — a cornerstone of its marketing strategy.

Winning a rickshaw in a race sponsored by the OM sports ministry team in Bangladesh changes Anwar's life and his family's life.

Known for his no-nonsense articulation of India's position on geopolitical issues, External Affairs Minister Dr S Jaishankar had a sharp response when an Australian journalist asked him if New Delhi recognises Canberra's "angst" over ties with Russia

Attorney General Kathy Jennings announced Thursday that Delaware and other states are suing search giant Google LLC for anticompetitive conduct in violation of Section 2 of the Sherman Act. The suit comes one week after Delaware announced a lawsuit against Facebook Inc. for violations of the Sherman Act and Clayton Act. “Google became a household […]

Chancery filing seeks invalidation of illegal fetal tissue ordinance After twice warning the City of Seaford that it was considering an anti-choice ordinance that was contrary to State law, Attorney General Kathy Jennings has filed suit against the City of Seaford over the ordinance.  The ordinance, passed on December 14 and scheduled to become effective […]

Chancery ruling invalidates illegal fetal tissue ordinance A fetal tissue ordinance enacted by Seaford City Council late last year has been overturned following a successful legal challenge by Attorney General Kathy Jennings and the Delaware Department of Justice. The ordinance, enacted on December 14 with an original effective date of January 22, would have forced […]

Attorney General Kathy Jennings and her colleagues have announced that a proposed settlement has been reached in the 2020 lawsuit against the Environmental Protection Agency (EPA) for its failure to require Pennsylvania to develop and implement a plan to meet its commitments to reduce pollution under the Chesapeake Clean Water Blueprint. One-third of Delaware is […]

Attorney General Kathy Jennings released the following statement Thursday after the Consumer Protection Financial Bureau and 11 states — including Delaware — announced a lawsuit against tech sales “bootcamp” Prehired, which Jennings previously announced the DOJ was investigating: “I applaud the Consumer Financial Protection Bureau and our sister states for taking action to hold Prehired […]

Attorney General seeks damages, including costs necessary to restore impacted natural resources and funding for State-run public health programs. Attorney General Kathleen Jennings announced that the Department of Justice has filed a lawsuit to hold numerous companies accountable for contaminating Delaware’s natural resources with per- and poly-fluoroalkyl substances (PFAS) traceable to the use and disposal […]

The Gulf region is making extensive reforms to its foreign investment landscape in an effort to attract foreign investors to sectors outside oil and gas, according to a recent report by PwC. 

Steve Armitage, general manager of destination at Auckland Tourism, Events and Economic Development explains why the New Zealand city’s international profile is growing so fast.

Proceeding to the discovery phase means both parties must collect and exchange evidence.

Daniele Oriti’s pursuit of a theory of quantum gravity has led him to the startling conclusion that the laws of nature don’t exist independently of us – a perspective shift that could yield fresh breakthroughs

Daniele Oriti’s pursuit of a theory of quantum gravity has led him to the startling conclusion that the laws of nature don’t exist independently of us – a perspective shift that could yield fresh breakthroughs

The symbols and mathematical operations used in the laws of physics follow a pattern that could reveal something fundamental about the universe

Title: Mandatory Life Jacket Laws Could Reduce Boating Deaths
Category: Health News
Created: 8/21/2015 12:00:00 AM
Last Editorial Review: 8/24/2015 12:00:00 AM

There's one cat in the mouse, but five folks on the cast. Alex apologizes for rocks. Kelley learns things by watching mew. Chris is watching RPGmaniacs. Anna Marie has started embalming ship girls. And Pascal flips coins to decide whether or not to open a site indexing body mutilation in films.

The post RPG Cast – Episode 564: “Paws Is Best Lederhosen” appeared first on RPGamer.

"Imagine you buy a pinball machine, and years later, you enter your den to go play it, only to discover that all the paddles are missing, the pinball and bumpers are gone, and the monitor that proudly displayed your unassailable high score is removed". As reported by Polygon, that's an argument put forth by a new lawsuit against Ubisoft, filed by two Californian players of The Crew. They're suing the company in a proposed class action lawsuit over shutting down the racing game's servers, rendering it unplayable.

Read more

As the space industry evolves, we need a new set of international regulations to decide who is responsible for safety, the number of satellites in space, and more

Astronomers listened for radio signals emanating from planets in the TRAPPIST-1 system, but found no evidence of any interplanetary communications

… a big upset in his Davis Cup debut on Friday, defeating Spaniard ….

… level with France in the Davis Cup quarterfinals Friday. The 20th-ranked Fognini … all five of his previous Davis Cup matches and beat Fognini recently ….

The Food and Drug Administration uses import alerts to enforce U.S. food safety regulations for food from foreign countries. The agency updates and modifies the alerts as needed. Recent modifications to FDA’s import alerts, as posted by the agency, are listed below. Use the chart below to view import alerts.... Continue Reading

Results reporting requirements are pretty clear. Maybe critics should re-check their methods?

Ben Goldacre has rather famously described the clinical trial reporting requirements in the Food and Drug Administration Amendments Act of 2007 as a “fake fix” that was being thoroughly “ignored” by the pharmaceutical industry.

Pharma: breaking the law in broad daylight?

He makes this sweeping, unconditional proclamation about the industry and its regulators on the basis of  a single study in the BMJ, blithely ignoring the fact that a) the authors of the study admitted that they could not adequately determine the number of studies that were meeting FDAAA requirements and b) a subsequent FDA review that identified only 15 trials potentially out of compliance, out of a pool of thousands.


Despite the fact that the FDA, which has access to more data, says that only a tiny fraction of studies are potentially noncompliant, Goldacre's frequently repeated claims that the law is being ignored seems to have caught on in the general run of journalistic and academic discussions about FDAAA.

And now there appears to be additional support for the idea that a large percentage of studies are noncompliant with FDAAA results reporting requirements, in the form of a new study in the Journal of Clinical Oncology: "Public Availability of Results of Trials Assessing Cancer Drugs in the United States" by Thi-Anh-Hoa Nguyen, et al.. In it, the authors report even lower levels of FDAAA compliance – a mere 20% of randomized clinical trials met requirements of posting results on clinicaltrials.gov within one year.

Unsurprisingly, the JCO results were immediately picked up and circulated uncritically by the usual suspects.

I have to admit not knowing much about pure academic and cooperative group trial operations, but I do know a lot about industry-run trials – simply put, I find the data as presented in the JCO study impossible to believe. Everyone I work with in pharma trials is painfully aware of the regulatory environment they work in. FDAAA compliance is a given, a no-brainer: large internal legal and compliance teams are everywhere, ensuring that the letter of the law is followed in clinical trial conduct. If anything, pharma sponsors are twitchily over-compliant with these kinds of regulations (for example, most still adhere to 100% verification of source documentation – sending monitors to physically examine every single record of every single enrolled patient - even after the FDA explicitly told them they didn't have to).

I realize that’s anecdotal evidence, but when such behavior is so pervasive, it’s difficult to buy into data that says it’s not happening at all. The idea that all pharmaceutical companies are ignoring a highly visible law that’s been on the books for 6 years is extraordinary. Are they really so brazenly breaking the rules? And is FDA abetting them by disseminating incorrect information?

Those are extraordinary claims, and would seem to require extraordinary evidence. The BMJ study had clear limitations that make its implications entirely unclear. Is the JCO article any better?

Some Issues

In fact, there appear to be at least two major issues that may have seriously compromised the JCO findings:

1. Studies that were certified as being eligible for delayed reporting requirements, but do not have their certification date listed.

The study authors make what I believe to be a completely unwarranted assumption:

In trials for approval of new drugs or approval for a new indication, a certification [permitting delayed results reporting] should be posted within 1 year and should be publicly available.

It’s unclear to me why the authors think the certifications “should be” publicly available. In re-reading FDAAA section 801, I don’t see any reference to that being a requirement. I suppose I could have missed it, but the authors provide a citation to a page that clearly does not list any such requirement.

But their methodology assumes that all trials that have a certification will have it posted:

If no results were posted at ClinicalTrials.gov, we determined whether the responsible party submitted a certification. In this case, we recorded the date of submission of the certification to ClinicalTrials.gov.

If a sponsor gets approval from FDA to delay reporting (as is routine for all drugs that are either not approved for any indication, or being studied for a new indication – i.e., the overwhelming majority of pharma drug trials), but doesn't post that approval on the registry, the JCO authors deem that trial “noncompliant”. This is not warranted: the company may have simply chosen not to post the certification despite being entirely FDAAA compliant.

2. Studies that were previously certified for delayed reporting and subsequently reported results

It is hard to tell how the authors treated this rather-substantial category of trials. If a trial was certified for delayed results reporting, but then subsequently published results, the certification date becomes difficult to find. Indeed, it appears in the case where there were results, the authors simply looked at the time from study completion to results posting. In effect, this would re-classify almost every single one of these trials from compliant to non-compliant. Consider this example trial:

• Phase 3 trial completes January 2010
• Certification of delayed results obtained December 2010 (compliant)
• FDA approval June 2013
• Results posted July 2013 (compliant)

In looking at the JCO paper's methods section, it really appears that this trial would be classified as reporting results 3.5 years after completion, and therefore be considered noncompliant with FDAAA. In fact, this trial is entirely kosher, and would be extremely typical for many phase 2 and 3 trials in industry.

Time for Some Data Transparency

The above two concerns may, in fact, be non-issues. They certainly appear to be implied in the JCO paper, but the wording isn't terribly detailed and could easily be giving me the wrong impression.

However, if either or both of these issues are real, they may affect the vast majority of "noncompliant" trials in this study. Given the fact that most clinical trials are either looking at new drugs, or looking at new indications for new drugs, these two issues may entirely explain the gap between the JCO study and the unequivocal FDA statements that contradict it.

I hope that, given the importance of transparency in research, the authors will be willing to post their data set publicly so that others can review their assumptions and independently verify their conclusions. It would be more than a bit ironic otherwise.
Thi-Anh-Hoa Nguyen, Agnes Dechartres, Soraya Belgherbi, and Philippe Ravaud (2013). Public Availability of Results of Trials Assessing Cancer Drugs in the United States JOURNAL OF CLINICAL ONCOLOGY DOI: 10.1200/JCO.2012.46.9577

A grand prize of $10 million is up for grabs at the upcoming Toto draw on Thursday (Nov 14) at 9.30pm. The Group 1 prize money has snowballed over the past three draws after no Group 1 winners were picked. According to Singapore Pools' website, the prize started at $1.2 million on Nov 4 before snowballing to $2.9 million on Nov 7 and $6 million on Nov 11. The last draw on Monday yielded three Group 2 winners who won $215,010 each. Tomorrow's draw will be a cascade draw, meaning that the prize money will be split between the Group 2 winners in the event that no Group 1 winner is chosen. If there are no Group 2 winners, the prize will be split among the Group 3 winners, and so on. The last time a Group 1 prize snowballed above $10 million was during the October 21 draw where two lucky winners bagged over $6.6 million each.