Osaka, Japan-based Diamond Electric Mfg. Co. Ltd. has agreed to plead guilty and to pay a $19 million criminal fine for its role in a conspiracy to fix prices of ignition coils installed in cars sold in the United States and elsewhere.

Conax Florida Corp. and related companies have agreed to resolve allegations under the False Claims Act that the company submitted false claims to the government for improperly tested inertia reels and non-conforming voltage references.

The Justice Department announced today that it will monitor elections on Sept. 10, 2013, in Cuyahoga County, Ohio, and in Queens County, N.Y. The monitoring will ensure compliance with the Voting Rights Act, which prohibits discrimination in the election process on the basis of race, color or membership in a minority language group.

A federal grand jury in Covington, Ky., has returned an indictment against G.S. Electech Inc. executive, Shingo Okuda for his role in an international conspiracy to fix prices and rig bids of auto parts used on antilock brake systems installed in U.S. cars.

The Justice Department announced today that it will monitor the special municipal election on Sept. 24, 2013, in Hattiesburg, Miss.

The Justice Department announced today that, jointly with the Commonwealth of Puerto Rico, it is moving in the U.S. District Court for the appointment of Juan Mattos Jr. as Technical Compliance Advisor (TCA).

The Justice Department announced today that it will monitor elections on Nov. 5, 2013, in Detroit and Hamtramck, Mich.; Orange County, N.Y.; and Cuyahoga and Lorain Counties, Ohio.

Quentin Collick of Montgomery, Ala., and Deatrice Williams of Duluth, Ga., were sentenced Nov. 1, 2013, to serve 85 and 51 months in prison, respectively, announced Assistant Attorney General Kathryn Keneally of the Justice Department's Tax Division and U.S. Attorney for the Middle District of Alabama George L. Beck Jr.

Attorney General Eric Holder today announced Ronald L. Davis as the director of the Office of Community Oriented Policing Services.

The Department of Justice’s Office on Violence Against Women (OVW), in partnership with the National Council of Juvenile and Family Court Judges (NCJFCJ), announces the selection of four courts to participate in the Family Court Enhancement Project (FCEP) to improve custody and visitation decision-making for families who have experienced domestic violence.

Stanley Electric Co. Ltd., a Tokyo-based company, has agreed to plead guilty and to pay a $1.44 million criminal fine for its participation in a conspiracy to fix prices of lamp ballasts installed in cars sold in the United States and elsewhere.

The Department of Justice today announced that it will require Heraeus Electro-Nite LLC to divest certain assets that it acquired from Midwest Instrument Company Inc. (Minco) to Keystone Sensors LLC in order to resolve the department’s competitive concerns.

Attorney General Eric Holder today announced that the Justice Department collected at least $8 billion in civil and criminal actions in the fiscal year ending Sept. 30, 2013.

A campaign worker was indicted yesterday by a federal grand jury in the Southern District of Texas for allegedly paying voters to vote in a Donna, Texas school board election. Two other campaign workers were indicted on similar charged last week for alleged vote-buying in the election.

The Justice Department announced today that General Electric Hitachi Nuclear Energy Americas LLC (GE Hitachi) has agreed to pay $2.7 million to resolve allegations under the False Claims Act that it made false statements and claims to the Department of Energy and the Nuclear Regulatory Commission (NRC) concerning an advanced nuclear reactor design.

The former president and vice president of Osaka, Japan-based Diamond Electric Mfg. Co. Ltd. have agreed to plead guilty for their participation in a global conspiracy to fix prices of ignition coils installed in cars sold in the United States and elsewhere.

Bill Melot, a farmer from Hobbs, N.M., was sentenced to serve 14 years in prison today to be followed by three years of supervised release for tax evasion, program fraud and other crimes, the Justice Department, Internal Revenue Service and U.S. Department of Agriculture’s Office of Inspector General announced.

Attorney General Eric Holder and Director of National Intelligence James Clapper released the following joint statement Wednesday.

“Earlier this year in a speech at the Department of Justice, President Obama announced a transition that would end the Section 215 bulk telephony metadata program as it existed, and that the government would establish a mechanism that preserves the capabilities we need without the government holding this bulk data," said Attorney General Holder and Director of National Intelligence James Clapper.

Sant Singh Chatwal, 70, of New York – a businessman operating several restaurants, hotels and a hotel management company – pleaded guilty in the Eastern District of New York to conspiring to violate the Federal Election Campaign Act.

On January 3, 2014, the Director of National Intelligence declassified and disclosed publically that the U.S. government had filed an application with the Foreign Intelligence Surveillance Court seeking renewal of the authority to collect telephony metadata in bulk, and that, the FISC renewed that authority. The Office of the Director National Intelligence also announced that the Administration was undertaking a declassification review of the FISC's January 3 primary order. On February 12, 2014, and following a declassification review by the Executive Branch, the FISC released in redacted form the previously classified January 3 primary order it had issued in Docket Number BR 14-01, along with a number of other documents.

Noting that African-American and Hispanic males are arrested at disproportionately high rates, U.S. Attorney General Eric Holder said Monday that the Justice Department will seek to collect data about stops, searches and arrests as part of a larger effort to analyze and reduce the possible effect of bias within the criminal justice system.

A campaign worker pleaded guilty today for paying voters to vote in the November 2012 school board election in Donna, Texas.

The Justice Department announced today that it will monitor elections on May 13, 2014, in Colfax and Douglas Counties, Nebraska, to ensure compliance with the Voting Rights Act and other federal voting rights statutes.

The Justice Department’s Civil Division announced today that Electrolux Home Products Inc., of Charlotte, North Carolina, has agreed to pay a civil penalty of $750,000 to settle allegations that it knowingly failed to report immediately to the U.S. Consumer Product Safety Commission a safety hazard associated with certain wall ovens sold to consumers.

Today, the Department of Justice and Office of the Director of National Intelligence released, in redacted form, a previously classified series of Foreign Intelligence Surveillance Court filings and orders from 2009-2010 concerning the collection of bulk telephony metadata under Section 215 of the USA Patriot Act. These documents relate to a robust interaction that occurred between the Department of Justice and a telecommunications service provider that included the provider’s review of prior FISC applications, orders and opinions, regarding lawful compliance with those orders.

Following a collaborative and thorough review, Attorney General Eric Holder on Thursday announced a new policy for the Department of Justice that creates a presumption that statements made by individuals in federal custody, following arrest but prior to their first appearance in court, will be electronically recorded. Attorney General Holder said that the new policy will help to ensure accountability and promote public confidence in the institutions and processes that guide the nation’s law enforcement efforts.

James Webb Baker Jr., of Seattle, pleaded guilty to one count of voter intimidation and one count of identification fraud in the U.S. District Court for the Middle District of Florida.

The Justice Department announced today that it will monitor elections on June 3, 2014, in Alameda and Napa Counties, California, and Cibola County, N.M., to ensure compliance with the Voting Rights Act and other federal voting rights statutes.

Today, U.S. District Judge Gustavo A. Gelpí approved the selection of Arnaldo Claudio to serve as Technical Compliance Advisor (TCA), overseeing the implementation of sweeping civil rights reforms under the Agreement for Sustainable Reform of the Puerto Rico Police Department.

"We support the USA Freedom Act as an effective means of addressing some of the concerns that have been raised about the impact of our intelligence collection activities on privacy while preserving the authorities we need for national security," said Deputy Attorney General Cooe.

Guadalupe Escamilla, 72, of Weslaco, Texas, pleaded guilty to one count of vote-buying before Chief U.S. District Judge Ricardo Hinojosa in the Southern District of Texas, McAllen Division.

The Justice Department and the Office of the Director of National Intelligence released the following joint statement Friday

The Department of Justice and the Office of the Director of National Intelligence (DNI) released the following statement Friday

This fourth annual report to Congress describes efforts to collect and improve data on crime and justice in Indian country, as required by the Tribal Law and Order Act of 2010. The report details the number of tribal law enforcement agencies reporting crime data to the FBI’s Uniform Crime Reporting program. It describes BJS’s first National Survey of Tribal Court Systems which will collect data on tribal courts in the lower 48 states and Alaska covering 566 tribes

An executive of Japanese auto parts maker G.S. Electech Inc. pleaded guilty and was sentenced today to serve 13 months in a U.S. prison for his role in an international conspiracy to rig bids and fix prices on auto parts used on antilock brake systems installed in U.S. cars, the Department of Justice announced

Samsung Electronics America Inc. (Samsung) has agreed to pay $2.3 million to resolve allegations that it caused the submission of false claims for products sold on General Service Administration (GSA) Multiple Award Schedule (MAS) contracts in violation of the Trade Agreements Act of 1979 (TAA), the Justice Department announced today. Samsung is an electronics distributor and marketer headquartered in Ridgefield Park, New Jersey

The Pew Charitable Trusts sent a letter May 4 to the leaders of the Senate and House of Representatives urging them to support improved patient matching in electronic health records to help combat the COVID-19 pandemic.

This blog post was written by Gerhard Koenig, CEO of Arkuda Therapeutics, as part of the From The Trenches feature of LifeSciVC. When I discussed the topic of writing about my experience as an immigrant biotech CEO with Bruce Booth,

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Emphasis on fat and protein intake, reduced carbohydrate intake and gut health for managing weight are trends affecting the global weight management category.

As a sponsor or CRO, you understand the importance of a thorough site selection process. A site needs to be able to meet enrollment targets and time frames, protect the rights and safety of study participants, execute the protocol, deliver quality data, and maintain GCP compliance. That’s what your site feasibility surveys and pre-study visits are designed to evaluate. And as you’re assessing a site’s abilities, the site is conducting its own feasibility process. They’re mining their patient database and assessing inclusion/exclusion criteria. They’re reviewing staff credentials and ensuring they have adequate resources to manage the number of subject visits and collect the data the protocol requires.

But when we conduct GCP audits, we find there’s one perspective that is sometimes overlooked by both sides: the needs of the study drug itself.




Study Drug Attributes Affecting Site Selection Process

IP Environment.  Aside from needing sufficient storage space, many drugs have special storage requirements. Does the site have the equipment and resources needed to maintain and adequately monitor and record environmental conditions such as temperature or humidity? Do they have agreements with their vendors that guarantee a specific response time for repairing or replacing faulty equipment? If they lose electricity, do they have back up power, or at least provisions to move the IP off-site? (This is a common auditor question in hurricane-prone areas.)


Preparation of Study Drug.  Does your investigational product need to be reconstituted in a liquid? Do doses need to be compounded in different concentrations? Does the protocol require that an IV solution be prepared, filtered, and sterilized? These activities take time, specially trained personnel, and sometimes specialized equipment such as ventilation hoods. If your protocol demands an involved IP prep, your feasibility survey must include questions that allow you to assess these site capabilities and your pre-study visit should definitely include some time in the pharmacy. 

Drug Administration. Handing over a bottle of capsules to a study participant is one thing; inserting a butterfly catheter into an antecubital vein is something else again. If drug administration is very invasive, you’ll want to verify that the site has taken this into account when providing you enrollment projections. During subject visits, staff members may have to calculate doses, give intramuscular injections, perform infusions, or conduct sterilization procedures. You’ll want to verify that site staff has this expertise if required. Some clinical trials require a blinded dispenser who cannot be involved in any other study procedure or activities. If so, does the site have the resources for this?

Site Selection: it’s not just the PI, it’s the IP too
The study success and patient safety are jeopardized when a site can’t meet its enrollment target or doesn’t have the resources to execute the protocol. IP requirements can affect a site’s ability to do both. It’s critical that your site selection process – both your feasibility questionnaire and your pre-study visit – evaluate how well the site can meet the storage, preparation, and administration requirements of the study drug.

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A version of this article originally appeared in InSite, the Journal of the Society for Clinical Research Sites.

Photo Credit: By Harmid (Own work) [Public domain], via Wikimedia Commons

March 23, 2020 – As the United States grapples with the COVID-19 outbreak and its ongoing fallout, there is another pressing issue that is crucial to the American public: ensuring safe and fair elections between now and Nov. 3. “The Coalition believes it is important for all Americans to be active in the political process […]

Parts of California, including Los Angeles County, are allowing some businesses to offer curbside service Friday.

By Karla L. Palmer —

Yokogawa Electric Corporation announces that Dr. Penny Chen of Yokogawa Corporation of America has been selected by Control, a prestigious and influential industry publication in the US, to be inducted into its Process Automation Hall of Fame, Class of 2020. Dr. Chen is senior principal technology strategist at Yokogawa Corporation of America's U.S. Technology Center based in Dallas, Texas.

The carrier strike group is expected to be deployed in the US Central Command region, where the US Navy currently has no aircraft carrier stationed.

The Series D+ round was led by state-owned China Internet Investment Fund.

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