Bruce Alan Edward, 48, of Atlanta, Mich., was charged in an indictment returned on Oct. 24, 2012, and unsealed on Nov. 1, 2012, by the federal grand jury in Bay City, Mich.

Amazon.com; Leon Max Inc., d/b/a Max Studio; Macy’s Inc.; and Sears, Roebuck and Co., Kmart Corporation and Kmart.com (collectively, Sears) have agreed to settle civil lawsuits concerning alleged violations of the Textile Fiber Product Identification Act and the Federal Trade Commission Act.

In a settlement with the United States on behalf of the U.S. Environmental Protection Agency, automotive electronics manufacturer Edge Products LLC (Edge) has agreed to pay a $500,000 civil penalty for manufacturing and selling electronic devices that allowed owners of model year 2007 and later diesel pickup trucks to remove emission controls from their vehicles.

Five individuals and five corporations have been charged in an indictment unsealed today in Brooklyn, N.Y., for allegedly importing hazardous and counterfeit toys from China for sale in the United States.

The Department of Justice Civil Rights Division and the U.S. Attorney’s Office for the District of Connecticut announced today, together with the town of East Haven, Conn., and the East Haven Board of Police Commissioners, they have selected Kathleen O’Toole as the Joint Compliance Expert to assess and report on the implementation of a comprehensive settlement agreement to reform the East Haven Police Department.

The United States and the city of New Orleans announced today that public meetings would be held regarding a consent decree court monitor for the New Orleans Police Department.

"Clarence Earl Gideon made a difference. Now it is up to every one of us to make his vision – and the words of the U.S. Supreme Court in his case – a reality. You have started on that path here in Texas," said Acting Senior Counselor Leff.

"It has indeed changed – but it has not changed as much as we would like, or as indigent defendants need, to achieve justice," said Acting Senior Counselor Leff.

A federal jury in Montgomery, Ala., found James Timothy Turner, also known as Tim Turner, guilty late Friday of conspiracy to defraud the United States, attempting to pay taxes with fictitious financial instruments, attempting to obstruct and impede the Internal Revenue Service, failing to file a 2009 federal income tax return and falsely testifying under oath in a bankruptcy proceeding.

The Department of Justice’s Office on Violence Against Women today announced a new Mentor Court Initiative to support criminal and civil domestic violence courts across the country.

Steven Patrick Garcia, Jr., 36, of San Jose, Calif., was sentenced today in federal court in Billings, Mont., to 24 months in prison to be followed by one year of supervised release for selling and offering to sell migratory bird parts in violation of the Migratory Bird Treaty Act (MBTA) and the Lacey Act, the Department of Justice announced today. Garcia had pleaded guilty to the charge on January 16, 2013.

Today’s agreement is about opportunity. It’s about growth. And it’s about human dignity. That’s because today’s agreement centers on integrating people with disabilities into the engine of the economic mainstream: the workplace.

Peter Picone, 40, of Methuen, Mass., has been charged with importing counterfeit semiconductors from China for sale in the United States.

Two shipping firms based in Germany and Cyprus were sentenced today in federal court in Newark, N.J., to pay a $10.4 million penalty for felony obstruction of justice charges and violating the Act to Prevent Pollution from Ships related to the deliberate concealment of vessel pollution from four ships that visited ports in New Jersey, Delaware and Northern California, the U.S. Attorney’s Offices in New Jersey and Delaware, the U.S. Department of Justice Environment and Natural Resources Division and the U.S. Coast Guard announced.

The Justice Department, the Internal Revenue Service (IRS) and the FBI announced today that James Timothy Turner, also known as Tim Turner, was sentenced to serve 18 years in federal prison for conspiracy to defraud the United States, attempting to pay taxes with fictitious financial instruments, attempting to obstruct and impede the IRS, failing to file a 2009 federal income tax return and falsely testifying under oath in a bankruptcy proceeding.

Southfield, Mich., resident Bashar Saroki pleaded guilty to filing a false tax return and selling drug paraphernalia, the Justice Department and the Internal Revenue Service (IRS) announced today.

Kan-Di-Ki LLC, formerly known as Kan-Di-Ki Inc., doing business as Diagnostic Laboratories and Radiology (Diagnostic Labs), will pay $17.5 million to settle allegations that the California-based company violated the federal and California False Claims Acts by paying kickbacks for referral of mobile lab and radiology services subsequently billed to Medicare and Medi-Cal (the state of California’s Medicaid program), the Justice Department announced today.

A Vietnamese national has been indicted in the District of New Hampshire for allegedly participating in an international scheme to steal and sell hundreds of thousands of Americans’ personally identifiable information (PII) through various underground websites that he operated.

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).

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.

"A key step in promoting greater public confidence in these intelligence activities is to provide greater transparency so that the American people, as well as ordinary citizens around the world, understand what the activities are, how they function, and how they are overseen."

Michigan-based Cadillac Asphalt LLC (Cadillac) and Michigan Paving and Materials Co. (MPM), have agreed to pay $3.8 million to resolve allegations that they falsely claimed Disadvantaged Business Enterprise (DBE) credits on a number of federally funded transportation projects.

Bashar Saroki, a resident of Southfield, Mich., was sentenced today in the U.S. District Court for the Eastern District of Michigan to serve 30 months in prison to be followed by one year of supervised release, the Justice Department and the Internal Revenue Service announced.

A federal jury in San Francisco has found two individuals and one company guilty of economic espionage, theft of trade secrets, bankruptcy fraud, tax evasion, and obstruction of justice for their roles in a long-running effort to obtain U.S. trade secrets for the benefit of companies controlled by the government of the People’s Republic of China.

Edward N. Levine, 63, of Mill Valley, Calif., and Lumsden W. Quan, 46, of San Francisco, were indicted by a federal grand jury in Las Vegas today for the illegal sale of two horns from an endangered black rhinoceros.

Peter Picone, 41, of Methuen, Massachusetts, pleaded guilty today in U.S. District Court in Hartford, Connecticut to importing thousands of counterfeit integrated circuits (ICs) from China and Hong Kong and then reselling them to U.S. customers.

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.

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]

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.

__________________________________________________________________________
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

Taiwanese biosimilars developer Mycenax announced on 28 April 2020 that it had made a deal with Hungary-based Gedeon Richter (Richter) regarding its tocilizumab biosimilar.

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

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 funding also saw the participation of Omidyar Network, Shunwei Capital, BCCL, and Nexus Venture Partners.

The post Tencent leads $9.4m funding in Indian self-publishing platform Pratilipi appeared first on DealStreetAsia.

Study finds an unusual technique for eating less

miRNA-targeted antimiRs conjugated to a peptide with a low pH–induced transmembrane structure (pHLIP) could help treat solid tumors.

May 7, 2020

Official figures exclude thousands who have died during the pandemic. To draw the right lessons, the United States needs an accurate tally of the victims.

May 7, 2020

Official figures exclude thousands who have died during the pandemic. To draw the right lessons, the United States needs an accurate tally of the victims.

May 7, 2020

Official figures exclude thousands who have died during the pandemic. To draw the right lessons, the United States needs an accurate tally of the victims.

Apr 9, 2020

Analysis of the West's differing responses to Ukrainian and Armenian mass movements reveal that, contrary to the popular Wilsonian narrative, the West assists democratic movements only when that assistance coincides with its material interests.

May 7, 2020

Official figures exclude thousands who have died during the pandemic. To draw the right lessons, the United States needs an accurate tally of the victims.