A Georgia real estate investor pleaded guilty today for his role in conspiracies to rig bids and commit mail fraud at public real estate foreclosure auctions in Fulton and DeKalb counties, Georgia

The former president and majority stockholder of a construction company was sentenced to five years in prison today following her plea of guilty to filing a false tax return and her conviction by a jury of conspiracy to defraud the United States, wire fraud, mail fraud, false statements, interstate transportation of property taken by fraud, conspiracy to obstruct justice and obstruction of justice, announced Acting Assistant Attorney General Caroline D. Ciraolo of the Justice Department’s Tax Division and U.S. Attorney Wendy J. Olson for the District of Idaho.

ALEXANDRIA, Va

By Ashley Henderson, PhD, CATO SMS Scientist 1.0 INTRODUCTION The COVID‑19 pandemic has added an unprecedented set of challenges to the conduct of clinical trials including quarantines, travel limitations, site closures, and interruptions in the supply chain of investigational products. In acknowledgement of these challenges, the Food and Drug Administration (FDA) recognizes that protocol modifications …

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DSM today published the first part of a new report in its Global Insight Series, focused on breakfast habits and behavior in Europe and the US.

The Council for Responsible Nutrition announced the launch of a consumer education initiative designed to raise awareness of Selective Androgen Receptor Modulators, a dangerous class of ingredients.

Members of the Asia-Pacific Economic Cooperation (APEC) will continue to work together towards more inclusive and sustainable growth, pledged APEC Senior Officials at the concluding event for Chile’s host year of APEC.

From : Communities>>Regulatory Open Forum
This message was posted by a user wishing to remain anonymous Dear RAPS members, I am preparing a submission for a device that has no special controls and we have identified the following standards to name a few. 62304-  ANSI AAMI IEC   62304:2006/A1:2016 62366-1:2015-  Medical Devices - Part 1: Application Of Usability Engineering To Medical Devices 14971- Medical Devices - Applications Of Risk Management To Medical Devices I am trying to see what approach will be good. Should I prepare a DOC or [More]

From : Communities>>Regulatory Open Forum
This message was posted by a user wishing to remain anonymous I'd recommend a statement that you are using these standards as general use. A Declaration of Conformity allows you to submit less testing information, but FDA still may request it. In the case of the standards you mentioned, FDA will require that information (e.g. software documentation, risk management, etc). So I would not bother with the DoC as you still have to submit all that material. Here was a nice thread discussing the topic [More]

From : Communities>>Regulatory Open Forum
Hello Anonymous  You will be generating software documents (which is data of a sort), in accordance  with  ANSI-AAMI IEC 62304, and there is output from ISO 14971 which goes into the submission.   I just think DoCs are wasteful busy time and would do as few as possible. Regarding IEC 62366-1, maybe if you want mention it and do a DoC, but if the device  usability  study is not required in a submission don't  put it in there unless asked.  Just my opinion. Biocompatibility if used, is generating test [More]

From : Communities>>Regulatory Open Forum
Hello, I agree with Ginger, when you look at standards there will most likely be an output of documents from following those standards, i.e. risk management file, usability report, all the software documentation.  These would be included in the different sections of the 510(k) so you can claim them as recognised standards you are following.  I have mentioned in previous posts, we take a simple approach for the declaration of conformity to standards that is a small table describing what we are complying, [More]

by Derek Willis

In an April report that warns of the risks of fraud in mail-in voting, a conservative legal group significantly inflated a key statistic, a ProPublica analysis found. The Public Interest Legal Foundation reported that more than 1 million ballots sent out to voters in 2018 were returned as undeliverable. Taken at face value, that would represent a 91% increase over the number of undeliverable mail ballots in 2016, a sign that a vote-by-mail system would be a “catastrophe” for elections, the group argued.

However, after ProPublica provided evidence to PILF that it had in fact doubled the official government numbers, the organization corrected its figure. The number of undeliverable mail ballots dropped slightly from 2016 to 2018.

The PILF report said that one in five mail ballots issued between 2012 and 2018, a total of 28.3 million, were not returned by voters and were “missing,” which, according to the organization, creates an opportunity for fraud. In a May 1 tweet that included a link to coverage of the report, President Donald Trump wrote: “Don’t allow RIGGED ELECTIONS.”

PILF regularly sues state and local election officials to force them to purge some voters from registration rolls, including those it claims have duplicate registrations from another state or who are dead. It is headed by J. Christian Adams, a former Justice Department attorney who was a member of the Trump administration’s disbanded commission on election integrity.

The report describes as “missing” all mail ballots that were delivered to a valid address but not returned to be counted. In a statement accompanying the report, Adams said that unaccounted-for ballots “represent 28 million opportunities for someone to cheat.” In particular, the organization argues that the number of unreturned ballots would grow if more states adopt voting by mail.

Experts who study voting and use the same data PILF used in the report, which is from the Election Administration and Voting Survey produced by the federal Election Assistance Commission, say that it’s wrong to describe unreturned ballots as missing.

“Election officials ‘know’ what happened to those ballots,” said Paul Gronke, a professor at Reed College, who is the director of the Early Voting Information Center, a research group based there. “They were received by eligible citizens and not filled out. Where are they now? Most likely, in landfills,” Gronke said by email.

A recent RealClear Politics article based on the PILF report suggested that an increase in voting by mail this year could make the kind of fraud uncovered in North Carolina’s 9th Congressional District in 2018 more likely. In that case, a political consultant to a Republican candidate was indicted on charges of absentee ballot fraud for overseeing a paid ballot collection operation. “The potential to affect elections by chasing down unused mail-in ballots and make sure they get counted — using methods that may or may not be legal — is great,” the article argues.

PILF’s report was mentioned in other news outlets including the Grand Junction Sentinel in Colorado, “PBS NewsHour” and the New York Post. The Washington Times repeated the inaccurate claim of 1 million undeliverable mail ballots.

In a statement, the National Vote at Home Institute, an advocacy group, challenged the characterization of the 28.3 million ballots as missing. Of those ballots, 12 million were mailed by election officials in Colorado, Oregon and Washington, which by law send a mail-in ballot to every registered voter, roughly 30% of which are not returned for any given election. “Conflating voters choosing not to cast their ballots with ‘missing’ ballots is a fundamental flaw,” the statement reads.

In an interview, Logan Churchwell, the communications director for PILF, acknowledged the error in the number of undelivered ballots, but defended the report’s conclusions, saying that it showed potential vulnerabilities in the voting system. “Election officials send these ballots out in the mail, and for them to say ‘I have no idea what happened after that’ speaks more to the investments they haven’t made to track them,” he said in a telephone interview.

But 36 states have adopted processes where voters and local officials can track the status of mail ballots through delivery, much like they can track packages delivered to a home. Churchwell said there are other explanations why mail ballots are not returned and that state and local election officials could report more information about the status of mail ballots. “If you know a ballot got to a house, you can credibly say that ballot’s status is not unknown,” he said.

The EAVS data has been published after every general election since 2004, although not every local jurisdiction provides complete responses to its questions.

In the data, election officials are asked to provide the number of mail ballots sent to voters, the number returned to be counted and the number of ballots returned as undeliverable by the U.S. Postal Service, which provides specific ballot-tracking services. The survey also asks for the number of ballots that are turned in or invalidated by voters who chose to cast their ballots in person. It asks officials to report the number of ballots that do not fit into any of those categories, or are “otherwise unable to be tracked by your office.”

Gronke described the last category as “a placeholder for elections officials to put numbers so that the whole column adds up,” and said that there was no evidence to support calling those ballots a pathway to large-scale voter fraud.

Numerous academic studies have shown that cases of voter fraud are extremely rare, although they do occur, and that fraud in mail voting seems to occur more often than with in-person voting.

by Alice Wilder, WNYC

Presidential lawyer and former New York City Mayor Rudy Giuliani has largely fallen out of the public eye since his starring role in President Donald Trump’s impeachment. But Giuliani hasn’t gone silent.

Instead, he’s in his home, doing a call-in radio show and a podcast — “Common Sense” — during which he has repeatedly gone on bigoted rants about China and its government.

“They have no morals,” he said on his April 28 radio show. “They’re amoral in the sense that human life means something in Western civilization, it means a lot. Human life doesn’t mean the same thing to them.”

Giuliani has also speculated that the spread of the coronavirus may be a plot by the Chinese government.

For example, Giuliani has raised the possibility that China purposely released the virus from a biological lab in Wuhan. “We have to say accidentally,” Giuliani said in a recent radio broadcast. “But I don’t think as responsible investigators we can rule out that it wasn’t done deliberately.”

Experts say there’s no public evidence the virus came from the lab. Amid a reported White House push, U.S. intelligence agencies have said they are investigating the origins of the virus.

Giuliani is also fixated on the idea that the Chinese government sent sick people overseas. In an April 27 episode of his podcast, he said that China allowed “over a million people from Wuhan travel to us, to the United States, to England to France to Italy to Germany.” He added, “I hope the people there have the same reaction we have to the value of human life and the loss of human life.”

“When they found out about this terrible virus that escaped, assuming they didn’t do it on purpose,” Giuliani said a day later on his radio show, “they were going to make sure the West suffered as much if not more than they did and jumped on top of an opportunity, it’s not a big assumption to make. And there isn’t a contrary explanation.”

The New York Times found that thousands, not millions, of people flew internationally out of Wuhan.

Asked about his comments, Giuliani did not respond.

The comments by Giuliani have come as discrimination against Asian Americans has spiked. And they reinforce the White House’s emerging push to blame China for the pandemic.

Giuliani has said he’s spoken to the president a number of times about the coronavirus. Two days after Giuliani said he was sure the virus came from the Wuhan lab, Trump said he has evidence of the same. (The president declined to give the evidence, saying it’s secret.)

Giuliani appears to have found a receptive wider audience too. An advertising executive at 77 WABC, which airs Giuliani’s radio show, said “feedback has been amazing” and online listening has “skyrocketed.”

The station’s parent company, Red Apple Media, did not respond to a request for comment.

In an April 23 radio show, Giuliani interviewed Gordon Chang, a conservative pundit who frequently predicts the collapse of the Chinese government. Chang said if China released the virus accidentally — for which, again, there’s no evidence — it then decided to create a global pandemic. “I think what Xi Jinping did was he decided he was going to spread the virus so that he would level the playing field so that China would not be in such a hole,” Chang said, referring to China’s president.

“Wow,” Giuliani responded. “So he saw an opportunity, if that theory is correct, and it wasn’t a bioweapon to start with, he saw an opportunity that was sort of accidentally presented to him, and then he took advantage of it. It was opportunistic.”

Chang acknowledged, “We can’t know what was in Xi Jinping’s mind for sure.” But then he went on, “It looks more like they were deliberate and malicious and that means Mr. Mayor ... this is a crime against all of humanity.”

Giuliani ended the interview by inviting Chang to be a guest on his other show, the podcast.

Giuliani has also said he’d use his access to help guests on his show move ahead with exploratory treatments. Talking with one pharmaceutical executive on his show in late March, Giuliani told his guest, “I’ll use whatever my yelling and screaming can do to do it faster, to help you.”

As the Times reported, the executive’s company received initial trial approval from the Food and Drug Administration soon after. (The FDA has said the application was subject to “internal scientific review.” And Giuliani has said he has no business connection to the company.)

“I don’t lobby the government,” Giuliani emailed in response to a request for comment. “I do hope, however, that they and others are successful.”

Giuliani appears to have strong feelings about the government’s process for approving drugs.

In an April 23 broadcast, Mark, a pharmacist from New Jersey, called in to report on his “informal study” of the patients who have used a drug cocktail that includes hydroxychloroquine — the anti-malaria drug that Trump long has touted.

Giuliani was excited when Mark reported that none of his patients had been hospitalized: “Why doesn’t this count with all these geniuses in Washington? The double blind study and the triple blind study and this study and that study, we don’t have time for that, we’ve got to go to people like Mark in New Jersey!”

In fact, the FDA has warned against widespread use of the drug, noting that it can cause heart problems.

The discussions with his listeners, though, often come back to China.

One caller to Giuliani’s radio show, identifying himself as “George from Bay Ridge,” went on a rant against Chinese people, likening them to serial killers with “no conscience” who are attempting to take over businesses all over the world.

Giuliani responded, “George, I’ve been getting complaints about this for a long time.” He added: “It almost reminds me of the Mafia. You know, they say, if you do business with America it’s one thing. If you do business with China you don’t realize, all of a sudden you start owing them too much and they believe they own you.”

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March 4, 2020 — The U.S. Supreme Court delivered a surprise on March 2 when it announced it will hear a challenge to the constitutionality of the Affordable Care Act (ACA) next term, leap-frogging over the process that was playing out in lower courts. Oral arguments have not yet been scheduled, but are likely to […]

While dietary supplement sales have surged in recent months, the extent of the economic damage caused by the novel coronavirus and COVID-19 could lead to some very tough quarters as families and businesses start to run out of money.

The dietary supplement industry as a whole is enjoying booming sales as consumer stock up on products to support optimum health. But an industry strategist warns that that sales bump is likely to be ephemeral, and brands that are not strategizing vigorously now may be caught out in the near future.

Recent research suggests that some brands may want to calm down their messaging.

Consumers are turning to dietary supplements in record numbers, but the industry must deliver on the results the products are promising if the industry is to convert them to long term customers, says Steve Mister.

The video has been viewed millions of times on YouTube via links that are replaced as quickly as the video-sharing service can remove them for violating its policy against "COVID-19 misinformation."

RBI Recruitment 2020 Notification is out at rbi.org.in. Check details here.

Neurologist Steven Laureys looks for signs of consciousness in unresponsive patients

Casero-Ripollés, Andreu Impact of Covid-19 on the media system. Communicative and democratic consequences of news consumption during the outbreak // Impacto del Covid-19 en el sistema de medios. Consecuencias comunicativas y democráticas del consumo de noticias durante el brote. El profesional de la información, 2020, vol. 29, n. 2. [Journal article (Unpaginated)]

Rodero, Emma La radio: el medio que mejor se comporta en las crisis. Hábitos de escucha, consumo y percepción de los oyentes de radio durante el confinamiento por el Covid-19. El profesional de la información, 2020, vol. 92, n. 3. [Journal article (Unpaginated)]

Apr 29, 2020

In this piece, we will look at the various public purpose considerations as they relate to the development of diagnostics, therapeutics, and vaccines for coronavirus. We explore the foreseeable risks to public safety of loosened regulation, ultimately arguing that even in times of crisis, accountable science and technology development is a choice we can make to protect the public and yield beneficial results, while considering both short- and long-term impacts. 

Apr 29, 2020

In this piece, we will look at the various public purpose considerations as they relate to the development of diagnostics, therapeutics, and vaccines for coronavirus. We explore the foreseeable risks to public safety of loosened regulation, ultimately arguing that even in times of crisis, accountable science and technology development is a choice we can make to protect the public and yield beneficial results, while considering both short- and long-term impacts. 

Apr 29, 2020

In this piece, we will look at the various public purpose considerations as they relate to the development of diagnostics, therapeutics, and vaccines for coronavirus. We explore the foreseeable risks to public safety of loosened regulation, ultimately arguing that even in times of crisis, accountable science and technology development is a choice we can make to protect the public and yield beneficial results, while considering both short- and long-term impacts. 

Jan 4, 2020

Americans would be wise to brace for war with Iran, writes Susan Rice.

"Full-scale conflict is not a certainty, but the probability is higher than at any point in decades. Despite President Trump’s oft-professed desire to avoid war with Iran and withdraw from military entanglements in the Middle East, his decision to order the killing of Maj. Gen. Qassim Suleimani, Iran’s second most important official, as well as Iraqi leaders of an Iranian-backed militia, now locks our two countries in a dangerous escalatory cycle that will likely lead to wider warfare."

Apr 12, 2020

Is indiscriminate loyalty what allies want? The First Taiwan Strait Crisis (1954–55) case suggests that allies do not desire U.S. loyalty in all situations. Instead, they want the United States to be a reliable ally, posing no risk of abandonment or entrapment.

Apr 29, 2020

In this piece, we will look at the various public purpose considerations as they relate to the development of diagnostics, therapeutics, and vaccines for coronavirus. We explore the foreseeable risks to public safety of loosened regulation, ultimately arguing that even in times of crisis, accountable science and technology development is a choice we can make to protect the public and yield beneficial results, while considering both short- and long-term impacts. 

Apr 29, 2020

In this piece, we will look at the various public purpose considerations as they relate to the development of diagnostics, therapeutics, and vaccines for coronavirus. We explore the foreseeable risks to public safety of loosened regulation, ultimately arguing that even in times of crisis, accountable science and technology development is a choice we can make to protect the public and yield beneficial results, while considering both short- and long-term impacts. 

Apr 12, 2020

Is indiscriminate loyalty what allies want? The First Taiwan Strait Crisis (1954–55) case suggests that allies do not desire U.S. loyalty in all situations. Instead, they want the United States to be a reliable ally, posing no risk of abandonment or entrapment.

Apr 29, 2020

In this piece, we will look at the various public purpose considerations as they relate to the development of diagnostics, therapeutics, and vaccines for coronavirus. We explore the foreseeable risks to public safety of loosened regulation, ultimately arguing that even in times of crisis, accountable science and technology development is a choice we can make to protect the public and yield beneficial results, while considering both short- and long-term impacts. 

Jan 4, 2020

Americans would be wise to brace for war with Iran, writes Susan Rice.

"Full-scale conflict is not a certainty, but the probability is higher than at any point in decades. Despite President Trump’s oft-professed desire to avoid war with Iran and withdraw from military entanglements in the Middle East, his decision to order the killing of Maj. Gen. Qassim Suleimani, Iran’s second most important official, as well as Iraqi leaders of an Iranian-backed militia, now locks our two countries in a dangerous escalatory cycle that will likely lead to wider warfare."

Apr 12, 2020

Is indiscriminate loyalty what allies want? The First Taiwan Strait Crisis (1954–55) case suggests that allies do not desire U.S. loyalty in all situations. Instead, they want the United States to be a reliable ally, posing no risk of abandonment or entrapment.

Nov 28, 2018

Russian President Vladimir Putin’s eschatological talk of nuclear Armageddon at this year’s Valdai forum has stirred up heated debates on how well his description of Russia’s potential use of nuclear weapons matches the country’s official military doctrine. However, a close look at Putin’s Oct. 18 remarks and Russia’s 2014 military doctrine reveals that, while Putin deviated from the language in the doctrine, he did not lie on the first use issue. Nor did he seem to be hinting at a shift in Russia’s nuclear posture. More likely, he was signaling to Washington that the existing nuclear arms control treaties need to remain in place for the sake of ensuring strategic stability in the U.S.-Russian nuclear dyad and avoiding an accidental war between the two countries.

Apr 29, 2020

In this piece, we will look at the various public purpose considerations as they relate to the development of diagnostics, therapeutics, and vaccines for coronavirus. We explore the foreseeable risks to public safety of loosened regulation, ultimately arguing that even in times of crisis, accountable science and technology development is a choice we can make to protect the public and yield beneficial results, while considering both short- and long-term impacts. 

Apr 12, 2020

Is indiscriminate loyalty what allies want? The First Taiwan Strait Crisis (1954–55) case suggests that allies do not desire U.S. loyalty in all situations. Instead, they want the United States to be a reliable ally, posing no risk of abandonment or entrapment.

Apr 29, 2020

In this piece, we will look at the various public purpose considerations as they relate to the development of diagnostics, therapeutics, and vaccines for coronavirus. We explore the foreseeable risks to public safety of loosened regulation, ultimately arguing that even in times of crisis, accountable science and technology development is a choice we can make to protect the public and yield beneficial results, while considering both short- and long-term impacts. 

Apr 29, 2020

In this piece, we will look at the various public purpose considerations as they relate to the development of diagnostics, therapeutics, and vaccines for coronavirus. We explore the foreseeable risks to public safety of loosened regulation, ultimately arguing that even in times of crisis, accountable science and technology development is a choice we can make to protect the public and yield beneficial results, while considering both short- and long-term impacts.