From : Communities>>Regulatory Open Forum
Hello Anon, In the version, I usually put the last year or the year generally recognised, e.g. ISO 14971 being 2007.  Then for the publication date, I do put the latest version when published so would be April 2010.  Because of the way standards are amended and revised, it can be quite difficult to determine what to put on the cover sheet.  I would also rely a bit on the Recognized Standards list the FDA publishes:  https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm  to list [More]

From : Communities>>Regulatory Open Forum
Hi All, Always appreciate and respect the great advice that comes through this forum: The scope of my question is CE Mark of a Class IIa medical device system under the MDD (and then eventually MDR): We have Class I devices which will be CE Marked through self-certification. These devices can be used with other CE marked products (not owned by us). One of which is not CE Marked as a medical device (conformity to machinery and low voltage directives). In terms of what we consider this vendor, what [More]

Vertex Pharmaceuticals announced a plan late Tuesday to begin trials before the end of the year of the third in its so-called “triple combo” of pills designed to treat as much as 90 percent of the 75,000 patients worldwide who suffer from cystic fibrosis. That news, announced in conjunction with the Boston-based drugmaker’s third-quarter financial results last night, spurred a 6 percent stock increase after hours, implying the company’s market cap could increase by about half a billion dollars…

by Robert Faturechi and Derek Willis

Sen. Richard Burr was not the only member of his family to sell off a significant portion of his stock holdings in February, ahead of the market crash spurred by coronavirus fears. On the same day Burr sold, his brother-in-law also dumped tens of thousands of dollars worth of shares. The market fell by more than 30% in the subsequent month.

Burr’s brother-in-law, Gerald Fauth, who has a post on the National Mediation Board, sold between $97,000 and $280,000 worth of shares in six companies — including several that have been hit particularly hard in the market swoon and economic downturn.

A person who picked up Fauth’s phone on Wednesday hung up when asked if Fauth and Burr had discussed the sales in advance.

In 2017, President Donald Trump appointed Fauth to the three-person board of the National Mediation Board, a federal agency that facilitates labor-management relations within the nation’s railroad and airline industries. He was previously a lobbyist and president of his own transportation economic consulting firm, G.W. Fauth & Associates.

Burr came under scrutiny after ProPublica reported that he sold off a significant percentage of his stocks shortly before the market tanked, unloading between $628,000 and $1.72 million of his holdings on Feb. 13 in 33 separate transactions. As chairman of the Senate Intelligence Committee and a member of the health committee, Burr had access to the government’s most highly classified information about threats to America’s security and public health concerns.

Before his sell-off, Burr had assured the public that the federal government was well-prepared to handle the virus. In a Feb. 7 op-ed that he co-authored with another senator, he said “the United States today is better prepared than ever before to face emerging public health threats, like the coronavirus.”

That month however, according to a recording obtained by NPR, Burr had given a VIP group at an exclusive social club a much more dire preview of the economic impact of the the coronavirus, warning it could curtail business travel, cause schools to be closed and result in the military mobilizing to compensate for overwhelmed hospitals.

The timing of Burr’s stock sales drew widespread outrage, allegations of insider trading, calls for his resignation and an FBI investigation.

Burr defended his actions, saying he relied solely on public information, including CNBC reports, to inform his trades and did not rely on information he obtained as a senator.

Fauth avoided between $37,000 and $118,000 in losses by selling off when he did, considering how steeply the companies’ shares fell in recent weeks, according to an analysis by Luke Brindle-Khym, a partner and general counsel of Manhattan-based investigative firm QRI. Brindle-Khym obtained Fauth’s financial disclosure from the Office of Government Ethics and shared it with ProPublica. Government forms only require that the value of stock trades be disclosed in ranges. After the February sales, the total value of Fauth’s individual stock holdings appears to be between $680,000 and $2 million.

Alice Fisher, Burr’s attorney, told ProPublica that “Sen. Burr participated in the stock market based on public information and he did not coordinate his decision to trade on Feb. 13 with Mr. Fauth.”

She did not respond to a question about whether Burr discussed anything he learned as a senator with Fauth or any other relatives.

A review of Fauth’s financial disclosure forms since 2017 show that he is not a frequent stock trader, but that he also had a major day of sales in August 2019.

On Feb. 13, Fauth or his spouse sold between $15,001 and $50,000 of Altria, the tobacco company; between $50,001 and $100,000 of snack food maker Mondelez International; and between $1,001 and $15,000 of home furnishings retailer Williams-Sonoma. He also sold stakes in several oil companies, which have been hit particularly hard, including between $15,001 and $50,000 of Chevron; between $1,001 and $15,000 of BP and between $15,001 and $50,000 of Royal Dutch Shell.

The finances of the Burrs and Fauths have intersected before. Federal Election Commission records show that Burr’s leadership PAC, Next Century Fund, has paid $120,348 since 2002 to his sister-in-law, Mary Fauth, Gerald’s wife, who serves as treasurer. The PAC has also paid $104,850 in rent and utilities over the same period to 116 S. Royal St. Partners, in which Gerald Fauth is a partner.

Do you have access to information about stock trading by Trump administration officials or members of Congress that should be public? Email robert.faturechi@propublica.org or reach him on Signal/WhatsApp at 213-271-7217. Here’s how to send tips and documents to ProPublica securely.

Update, May 6, 2020: This story was updated with new comment from Sen. Richard Burr’s attorney.

Some producers of essential oils have thrown their hats into the coronavirus claims ring, according to recent warning letters from the US Food and Drug Administration and the Federal Trade Commission.

The coronavirus outbreak makes finding jobs more difficult for everyone. College seniors face unique career challenges.

By Rachael E. Hunt —

RBI Assistant Result 2020 out @ rbi.co.in of the prelims exam held for the recruitment of over 900 vacancies in central bank. Check your result on direct link here and know your marks of RBI Assistant Prelims 2020. Know RBI Assistant cut off marks and Mains Exam Date.

SBI Clerk Cut off 2020 is provided here of the Prelims exam held in February and March 2020. The official SBI Clerk Cut-off to release soon along with prelims exam result at sbi.co.in. Know the expected cut off marks of SBI Clerk Prelims 2020 exam for GEN/OBC/SC/ST/PwD category candidates and Previous years official cut off. 

Marknum Technology has secured $14 million in its Series B round led by Aurora Private Equity and GSR Ventures. 

The post China Digest: Marknum nets over $14m; SDIC invests in HGZ appeared first on DealStreetAsia.

Studies in patient samples and cell culture suggest let-7c, miR-99a and miR-125b could serve as prognostic markers in patients with estrogen receptor–positive luminal breast cancers.

Genomewide association studies identified four genes that could serve as diagnostic markers and/or therapeutic targets for EoE.

Genocea has identified an immunological imprint in patients with malaria and is using a $1.2 million grant from the Gates Foundation to turn the findings into a vaccine.

Apr 7, 2020

Henry Kissinger warns that many existing domestic and international institutions that have helped govern the past decades will not survive the Covid-19 crisis. He is surely correct.

Apr 7, 2020

Henry Kissinger warns that many existing domestic and international institutions that have helped govern the past decades will not survive the Covid-19 crisis. He is surely correct.

Mar 19, 2020

This paper examines a recent, rapid, and ongoing transition of India's lighting market to light emitting diode (LED) technology, from a negligible market share to LEDs becoming the dominant lighting products within five years, despite the country's otherwise limited visibility in the global solid-state lighting industry.

Dec 10, 2019

In this report, the authors conduct a benchmarking analysis for energy and CO2 emissions intensity of the steel industry among the largest steel-producing countries.

Mar 4, 2020

To accelerate the global transition to a low-carbon economy, all energy systems and sectors must be actively decarbonized. While hydrogen has been a staple in the energy and chemical industries for decades, renewable hydrogen is drawing increased attention today as a versatile and sustainable energy carrier with the potential to play an important piece in the carbon-free energy puzzle. Countries around the world are piloting new projects and policies, yet adopting hydrogen at scale will require innovating along the value chains; scaling technologies while significantly reducing costs; deploying enabling infrastructure; and defining appropriate national and international policies and market structures.

What are the general principles of how renewable hydrogen may reshape the structure of global energy markets? What are the likely geopolitical consequences such changes would cause? A deeper understanding of these nascent dynamics will allow policy makers and corporate investors to better navigate the challenges and maximize the opportunities that decarbonization will bring, without falling into the inefficient behaviors of the past.

Mar 19, 2020

This paper examines a recent, rapid, and ongoing transition of India's lighting market to light emitting diode (LED) technology, from a negligible market share to LEDs becoming the dominant lighting products within five years, despite the country's otherwise limited visibility in the global solid-state lighting industry.

Apr 7, 2020

Henry Kissinger warns that many existing domestic and international institutions that have helped govern the past decades will not survive the Covid-19 crisis. He is surely correct.

Apr 7, 2020

Henry Kissinger warns that many existing domestic and international institutions that have helped govern the past decades will not survive the Covid-19 crisis. He is surely correct.

Apr 7, 2020

Henry Kissinger warns that many existing domestic and international institutions that have helped govern the past decades will not survive the Covid-19 crisis. He is surely correct.

Dec 10, 2019

In this report, the authors conduct a benchmarking analysis for energy and CO2 emissions intensity of the steel industry among the largest steel-producing countries.

Mar 4, 2020

To accelerate the global transition to a low-carbon economy, all energy systems and sectors must be actively decarbonized. While hydrogen has been a staple in the energy and chemical industries for decades, renewable hydrogen is drawing increased attention today as a versatile and sustainable energy carrier with the potential to play an important piece in the carbon-free energy puzzle. Countries around the world are piloting new projects and policies, yet adopting hydrogen at scale will require innovating along the value chains; scaling technologies while significantly reducing costs; deploying enabling infrastructure; and defining appropriate national and international policies and market structures.

What are the general principles of how renewable hydrogen may reshape the structure of global energy markets? What are the likely geopolitical consequences such changes would cause? A deeper understanding of these nascent dynamics will allow policy makers and corporate investors to better navigate the challenges and maximize the opportunities that decarbonization will bring, without falling into the inefficient behaviors of the past.

Mar 19, 2020

This paper examines a recent, rapid, and ongoing transition of India's lighting market to light emitting diode (LED) technology, from a negligible market share to LEDs becoming the dominant lighting products within five years, despite the country's otherwise limited visibility in the global solid-state lighting industry.

Mar 19, 2020

This paper examines a recent, rapid, and ongoing transition of India's lighting market to light emitting diode (LED) technology, from a negligible market share to LEDs becoming the dominant lighting products within five years, despite the country's otherwise limited visibility in the global solid-state lighting industry.

Mar 19, 2020

This paper examines a recent, rapid, and ongoing transition of India's lighting market to light emitting diode (LED) technology, from a negligible market share to LEDs becoming the dominant lighting products within five years, despite the country's otherwise limited visibility in the global solid-state lighting industry.

Dec 10, 2019

In this report, the authors conduct a benchmarking analysis for energy and CO2 emissions intensity of the steel industry among the largest steel-producing countries.

Mar 4, 2020

To accelerate the global transition to a low-carbon economy, all energy systems and sectors must be actively decarbonized. While hydrogen has been a staple in the energy and chemical industries for decades, renewable hydrogen is drawing increased attention today as a versatile and sustainable energy carrier with the potential to play an important piece in the carbon-free energy puzzle. Countries around the world are piloting new projects and policies, yet adopting hydrogen at scale will require innovating along the value chains; scaling technologies while significantly reducing costs; deploying enabling infrastructure; and defining appropriate national and international policies and market structures.

What are the general principles of how renewable hydrogen may reshape the structure of global energy markets? What are the likely geopolitical consequences such changes would cause? A deeper understanding of these nascent dynamics will allow policy makers and corporate investors to better navigate the challenges and maximize the opportunities that decarbonization will bring, without falling into the inefficient behaviors of the past.

Mar 19, 2020

This paper examines a recent, rapid, and ongoing transition of India's lighting market to light emitting diode (LED) technology, from a negligible market share to LEDs becoming the dominant lighting products within five years, despite the country's otherwise limited visibility in the global solid-state lighting industry.

Mar 19, 2020

This paper examines a recent, rapid, and ongoing transition of India's lighting market to light emitting diode (LED) technology, from a negligible market share to LEDs becoming the dominant lighting products within five years, despite the country's otherwise limited visibility in the global solid-state lighting industry.

Apr 7, 2020

Henry Kissinger warns that many existing domestic and international institutions that have helped govern the past decades will not survive the Covid-19 crisis. He is surely correct.

The Aye-aye is endangered and on the IUCN red list due to hunting and habitat destruction caused largely by humans setting fi res, illegal logging, making charcoal, as well as agriculture and livestock expansion.

Apr 7, 2020

Henry Kissinger warns that many existing domestic and international institutions that have helped govern the past decades will not survive the Covid-19 crisis. He is surely correct.

Apr 7, 2020

Henry Kissinger warns that many existing domestic and international institutions that have helped govern the past decades will not survive the Covid-19 crisis. He is surely correct.

Mar 19, 2020

This paper examines a recent, rapid, and ongoing transition of India's lighting market to light emitting diode (LED) technology, from a negligible market share to LEDs becoming the dominant lighting products within five years, despite the country's otherwise limited visibility in the global solid-state lighting industry.

Apr 7, 2020

Henry Kissinger warns that many existing domestic and international institutions that have helped govern the past decades will not survive the Covid-19 crisis. He is surely correct.

Mar 19, 2020

This paper examines a recent, rapid, and ongoing transition of India's lighting market to light emitting diode (LED) technology, from a negligible market share to LEDs becoming the dominant lighting products within five years, despite the country's otherwise limited visibility in the global solid-state lighting industry.