The United States has entered into a settlement agreement with the Kerr-McGee Corporation and certain of its affiliates (“New Kerr-McGee”), and their parent Anadarko Petroleum Corporation, in a fraudulent conveyance case brought by the United States and co-plaintiff Anadarko Litigation Trust (the “Trust”) in the bankruptcy of Tronox Inc. and its subsidiaries (Tronox), announced Deputy Attorney General James Cole, Acting Assistant Attorney General for the Justice Department’s Environment and Natural Resource Division Robert G. Dreher, U.S. Attorney for the Southern District of New York Preet Bharara, and U.S. Environmental Protection Agency Assistant Administrator Cynthia Giles.

The Justice Department announced today that it has entered into a statewide settlement agreement that will resolve violations of the Americans with Disabilities Act for approximately 3,250 Rhode Islanders with intellectual and developmental disabilities.

"Unnecessary segregation of people with disabilities is harmful to people with disabilities and to our communities. We cannot wait another day to change. And we won’t. Because today, the Justice Department, the state of Rhode Island and the business community, together, embrace real integration of people with disabilities – committing to make Rhode Island a model for other states to follow."

I believe that the only real, sustainable choice – the only safe and humane option – is the one that broadens opportunity and widens the path to success. Each of you is helping to lead us in that direction, and we are marching forward with you. And I am optimistic that we will continue to see an America that is safer, healthier, and more just.

Five California-based masonry subcontractors and two individuals paid the government nearly $1.9 million to resolve allegations that they violated the False Claims Act by misrepresenting their disadvantaged small business status in connection with military construction contracts.

Hope Cancer Institute, a cancer treatment facility in Kansas, and Dr. Raj Sadasivan, the owner of Hope Cancer Institute, have agreed to pay $2.9 million to resolve allegations that they violated the False Claims Act by submitting claims to Medicare, Medicaid and the Federal Employee Health Benefits Program for drugs and services that were not provided to beneficiaries.

The Department of Justice announced today that it has entered into a settlement agreement that, if approved by the court, will resolve allegations that the California Department of Corrections and Rehabilitation discriminated against an employee because of his sex in violation of Title VII of the Civil Rights Act of 1964.

The Department of Justice announced today that CRC Health Corp. (CRC) has agreed to pay $9.25 million to the federal government and the State of Tennessee to settle allegations that CRC knowingly submitted false claims by providing substandard treatment to adult and adolescent Medicaid patients suffering from alcohol and drug addiction at its facility in Burns, Tenn.

The International Competition Network (ICN) adopted new recommended practices for predatory pricing analysis and competition assessment, and approved new work product on international merger enforcement cooperation, confidentiality protections during investigations, leniency policy and digital evidence gathering.

Zdenko Jakiša, 45, of Forest Lake, Minnesota, was arrested today on immigration fraud charges for failing to disclose multiple crimes committed in Bosnia-Herzegovina and his military service during the armed conflict there in the 1990s.

Attorney General Eric Holder and Secretary of Education Arne Duncan will hold a press conference to announce a major law enforcement action to protect military servicemembers from unfair lending practices today, Tuesday, May 13, 2014, at 1:15 p.m. EDT.

The Department of Justice today announced the federal government’s first lawsuit filed against owners and servicers of student loans for violating the rights of servicemembers eligible for benefits and protections under the Servicemembers Civil Relief Act (SCRA).

"By requiring Sallie Mae to compensate its victims, we are sending a clear message to all lenders and servicers who would deprive our servicemembers of the basic benefits and protections to which they are entitled: this type of conduct is more than just inappropriate; it is inexcusable. And it will not be tolerated."

Speaking in a video message posted on the Justice Department’s website, Attorney General Eric Holder on Wednesday called for an end to the excessive use of solitary confinement for youth that suffer from mental illness. Attorney General Holder said the practices can have lasting, substantial effects on young people that could result in self-harm or, in some cases, even suicide.

A grand jury in the Western District of Pennsylvania (WDPA) indicted five Chinese military hackers for computer hacking, economic espionage and other offenses directed at six American victims in the U.S. nuclear power, metals and solar products industries.

When a foreign nation uses military or intelligence resources and tools against an American executive or corporation to obtain trade secrets or sensitive business information for the benefit of its state-owned companies, we must say, ‘enough is enough.’

At the Department of Justice, we have repeatedly pledged that we would do more to hold accountable those that engage in these actions. Today, we begin to fulfill that pledge.

The Justice Department filed a joint motion today for entry of a landmark consent decree to resolve allegations that the Law School Admission Council engaged in widespread and systemic discrimination in violation of the Americans with Disabilities Act.

United States Army soldier Albert Kelly III of Fort Campbell, Kentucky, was sentenced to serve 18 months in prison for his role in stealing fuel at Forward Operating Base (FOB) Salerno in Afghanistan.

Scott B. Miserendino, Sr., 55, a former government contractor who performed work for the United States Navy Military Sealift Command, and Timothy S. Miller, 57, a businessman whose company sought contracting business from the Military Sealift Command, were indicted today on charges including conspiracy and bribery.

The Justice Department filed a lawsuit today against Mississippi-based developer Dawn Properties Inc. and its affiliated companies for violating the Fair Housing Act and the Americans with Disabilities Act., alleging that the defendants violated these laws when they designed and constructed five or more residential properties with barriers that make them inaccessible to persons with disabilities

Eric Omuro, of Mountain View, California, a.k.a “Red,” was arrested today following his indictment by a federal grand jury on charges involving the use of the mail and the Internet to facilitate prostitution, and multiple counts of money laundering

In a settlement with the United States, Minnesota Power (MP), an ALLETE company based in Duluth, Minnesota has agreed to install pollution control technology and meet stringent emission rates to reduce harmful air pollution from the company’s three coal-fired power plants located in Cohasset, Hoyt Lakes and Schroeder, Minnesota, the Department of Justice and the U.S. Environmental Protection Agency (EPA) announced today

The Justice Department announced today that Attorney General Eric Holder has signed a Notice of Proposed Rulemaking (NPRM) to amend the Title III regulation for the Americans with Disabilities Act (ADA) to require movie theaters to provide closed movie captioning and audio description in order to give persons with hearing and vision disabilities access to movies

Kenny E. Toy, 54, the former Afloat Programs Manager at the United States Navy Military Sealift Command, was sentenced today to serve 96 months in prison for receiving bribes

A former employee of a government contracting company was sentenced today to 36 months in prison to be followed by three years of supervised release for conspiracy to bribe public officials at the United States Navy Military Sealift Command in exchange for favorable treatment in connection with U.S. government contract work

The Department of Justice filed a settlement today with Fifth Third Mortgage Company to resolve allegations that it engaged in a pattern or practice of discrimination on the basis of disability and receipt of public assistance in violation of the Fair Housing Act (FHA) and the Equal Credit Opportunity Act (ECOA). Under the settlement, Fifth Third has agreed to maintain revised policies, conduct employee training and pay over $1.5 million to compensate victims

The Justice Department announced today that it has entered into a settlement agreement with the Louisiana Supreme Court that will resolve the department’s investigation of the court’s policies, practices and procedures for evaluating bar applicants with mental health disabilities. The department’s investigation found that during the Louisiana bar admissions process licensing entities based recommendations about bar admission on mental health diagnosis and treatment rather than conduct that would warrant denial of admission to the bar

The Justice Department announced today that the owners and operators of the Alger Meadows Apartments in Grand Rapids, Michigan, have agreed to pay $550,000 in damages and civil penalties and to terminate property manager Dale VanderVennen’s role in managing the complex to settle a lawsuit alleging that VanderVennen sexually harassed female tenants in violation of the Fair Housing Act (FHA).

The Justice Department today announced that it has reached an agreement with the city of Baltimore, Maryland, to end hiring practices that discriminate against people with disabilities. The agreement, filed as a consent decree along with a complaint in the U.S. District Court for the District of Maryland, resolves allegations by the department that the city engaged in a pattern or practice of discrimination under the Americans with Disabilities Act (ADA). Title I of the ADA prohibits employers from discriminating against individuals on the basis of disability in various aspects of employment, including hiring

Political consultant Gregory Naylor, 66, of Philadelphia, pleaded guilty today to making false statements to federal agents and misprision of a felony in connection with his role in attempting to conceal two campaign finance-related fraud schemes

A New Jersey man pleaded guilty today to orchestrating an eight-year scheme to falsify employment certifications to facilitate the illegal entry of Indian immigrants into the United States and to filing a false tax return.

Life Care Services LLC, a manager of skilled nursing facilities based in Des Moines, Iowa, and CoreCare V LLP, doing business as ParkVista, a skilled nursing facility in Fullerton, California, have agreed to pay a total of $3.75 million to the government for causing the submission of false claims to Medicare for unreasonable or unnecessary rehabilitation therapy purportedly provided by RehabCare Group East Inc., a subsidiary of Kindred Healthcare Inc.

The Justice Department today filed a lawsuit against the Kent State University, the Kent State University Board of Trustees and university officials for violating the Fair Housing Act by discriminating against students with disabilities in student housing.

On January 15, 2009, the U.S. Foreign Intelligence Surveillance Court of Review (FISC-R) published an unclassified version of its opinion in In Re: Directives Pursuant to Section 105B of the Foreign Intelligence Surveillance Act, 551 F.3d 1004 (Foreign Intel. Surv. Ct. Rev. 2008). The classified version of the opinion was issued on August 22, 2008, following a challenge by Yahoo! Inc. (Yahoo!) to directives issued under the Protect America Act of 2007 (PAA). Today, following a renewed declassification review, the Executive Branch is publicly releasing various documents from this litigation, including legal briefs and additional sections of the 2008 FISC-R opinion, with appropriate redactions to protect national security information. These documents are available at the website of the Office of the Director of National Intelligence (ODNI), www.dni.gov; and ODNI’s public website dedicated to fostering greater public visibility into the intelligence activities of the U.S. Government, IContheRecord.tumblr.com. A summary of the underlying litigation follows.

Episcopal Ministries to the Aging Inc., a Maryland not-for-profit corporation that owns skilled nursing facilities, has agreed to pay $1.3 million to the government for submitting false claims to Medicare for unreasonable or unnecessary rehabilitation therapy purportedly provided by RehabCare Group East Inc., a subsidiary of Kindred Healthcare Inc.

In a settlement with the United States, Consumers Energy, a subsidiary of CMS Energy Corporation, has agreed to install pollution control technology, continue operating existing pollution controls and comply with emission rates to reduce harmful air pollution from the company’s five coal-fired power plants.

Remarks as prepared for delivery

Thank you, Professor [Jennifer] Arlen, for that kind introduction and for everything you and your colleagues have accomplished at NYU

Ocean Spray Cranberries, Inc. is recalling Pink Lite Cranberry Juice Drink citing potential for undeclared sulfites, the U.S. Food and Drug Administration said in a statement. The recall involves a single production lot of 5.5oz cans of the drink with lot number MH0030LPK4 and Best Before Date of 24JAN21. The product is sold in boxes containing six 5.5oz cans. They were distributed to retail

BASF recently announced the launch of Accelon™ absorption accelerating technology, developed as a breakthrough solution to the bioavailability challenge of today’s omega-3 supplements.

Alkemist Labs is pleased to announce a move to a new facility with over four times more space to expand capacity and accommodate continued growth.

Broaden opportunities for people and ensure more inclusive growth across the Asia-Pacific, urged the 2020 Chair of APEC Senior Officials, host of the Asia-Pacific Economic Cooperation in 2020.

From : Communities>>Regulatory Open Forum
This message was posted by a user wishing to remain anonymous For device-lead drug combination products, is there any difference in the quality (grade) of API used compared to a pure drug product? The cGMP guidance for combination products does not seem to specify, and since drug claims cannot be made on device-lead drug combination products, it was not clear what quality of drug is required. Thank you!

From : Communities>>Regulatory Open Forum
​I doubt FDA would have any willingness to change the requirements or expectations for a drug product based on whether it is in a strictly drug product versus in a combination product.  The fact also that there is not a published allowance for this is further evidence that FDA expects that the drug will meet the requirements as expected for drug products without providing any allowed changes or classes of changes.  Remember, FDA expects that drug products meet specific requirements.  Things like [More]

By Laurie Meehan

“I can’t get the IWRS to assign a kit number.”

“My ECG reports take forever to come back from the Core Lab.”

“The eCRF won’t let me create a new subject.”

“This stupid machine is blinking an error code again.”

Sound familiar?  Sprinkle in some colorful adjectives and it probably does -- these problems are common enough at clinical research sites.  Equipment and systems have become increasingly technical and specialized, and study site staff has had to contend with more technology than ever before.  And because of the proliferation of niche vendors who provide the new tech, sites have had to deal with more vendors than ever before, too.  



And how are problems like these typically resolved?  Someone at the study site works his/her way through a list of maybe 20 or more vendor contact numbers, places a call, navigates a series of menu options, and hopefully gets directed to someone who can help.  And that assumes the site calls the right company; with tightly integrated systems, it’s not always obvious in which vendor’s system the problem lies.  This is frustrating for sites.  It takes time.  It costs money (since “vendor wrangling” is seldom sufficiently covered in the budget).  And it keeps study staff from doing what study staff does best – run the study, work with the study volunteers, and keep them safe.

So what’s the solution? 

Hint: It’s Not Training
Calm down.  Of course, adequate training on equipment and systems is important. But training doesn’t solve every problem.  Training doesn’t keep equipment from malfunctioning.  Training doesn’t ensure vendors deliver what and when they’ve promised.  Training can’t anticipate every situation nor address an unusual site circumstance.  And training doesn’t turn people into infallible little machines; we make mistakes.  And so, in all these cases, we’re back to site personnel interacting with perhaps scores of vendors, by phone or email, all over the world.

The Solution: a Single Point of Contact
Q: How do you help sites interact with dozens of vendors?
A:  You don’t.  You do it for them.  Establish a single point of contact within the Sponsor* organization for a site to call when vendor issues arise. 

Why is this a good idea when the expertise to resolve the issue lies with the vendor?  Why is this a good idea when the introduction of a middleman may result in some inefficiencies?

Excellent questions.  Here are our responses. 

• Better Vendor Oversight.  When sites filter their vendor issues through the Sponsor, the Sponsor can more easily track vendor performance.  Are there vendors that provide low-quality solutions, are repeatedly late, or difficult to deal with?  At best, these vendors are wasting time and money, and aren’t good for business (let alone site relations).  At worst, these vendors are jeopardizing subject safety or study data integrity, and require immediate Sponsor intervention.

• Better Site Oversight.  When sites filter their vendor issues through the Sponsor, the Sponsor can more easily track site performance.  Are there sites that routinely use equipment and computer systems incorrectly?  (Yes, now’s the time for that training.)  Are there high-performing sites that are able to work independently?  This information has always been important, but in an RBM paradigm, it’s essential.  Adaptive monitoring plans rely on on-going site performance measurements so Sponsors can adjust resources accordingly.  A reduction in monitoring visits means less opportunity to assess a site’s comfort level with study technology.  The corollary of “if it ain’t broke, don’t fix it” is “if you don’t know it’s broke, you can’t fix it.”

• Ability to Identify Pervasive Problems. After the third or fourth site reports the same problem, it’s clear that this is not an isolated occurrence.  Knowing that, the Sponsor can work with the vendor to resolve the problem before other sites experience the same troubles.

• Better Functioning Sites.  We have a saying: “The Site Comes First."™  In our experience, all things being equal, Sponsors that put their sites first -- make things as easy as possible for the study coordinators -- get the best results.  They also build the good relationships that keep the best sites coming back to work on future studies.

• Better Functioning Vendors.  The efficiencies for the vendor here are clear.  Who wouldn’t rather interact with a single point of contact than field individual calls from multiple study sites?  Plus, with far fewer players, miscommunicating both problem descriptions and problem solutions is less likely to occur.  The Sponsor contact and the vendor contacts will eventually settle into common terminology and build a history regarding past issues and resolutions.

What Do You Think?
We know that not everyone espouses this idea, and we recognize there are probably other effective processes out there.  Sponsors, how do you help your sites deal with multiple vendors?  Sites, do you have experiences and/or suggestions you can share?  (Be kind, anonymize!)  Leave a comment here, visit our website, or send us an email.




____________________
*When we use the term “Sponsors” in this post, we’re including CROs that take on Vendor Management responsibilities on behalf of Sponsors.

The facility will be the companyâs second facility in Carlsbad specifically for its BioReliance viral and gene therapy service.

With the COVID-19 impact making itself apparent on a daily basis as the numbers climb and organizations respond, the effects on the pharma and biotech sector also shifts. Yesterday FDA announced a new concentration of agency assets to be focused … Continue reading →

Posted by Roger Bate The Economic Times of India covered our new paper today (see here). The paper published by the National bureau of Economic Research and not AEI as claimed by the Economic Times (see here), shows that Indian firms send their worst quality medicines to Africa. It is a shame that Indian Industry hack DG Shah continues to trot out the same arguments attacking us rather than addressing the paper’s findings. For example, he asks why did it take so long to publish a study [...]