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United States Seeks Civil Contempt Against Bayer Corporation for Failure to Substantiate Promotional Claims for Phillips’ Colon Health

The Department of Justice announced today that it filed a motion to show cause why Bayer Corporation should not be held in civil contempt for violating a court order in the U.S. District Court for the District of New Jersey.



  • OPA Press Releases

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Community Oriented Policing Services Outlines Best Practices for Use of Body-Worn Cameras for Police Officers

Today the U.S. Department of Justice Office of Community Oriented Policing Services (COPS Office) released Implementing a Body-Worn Camera Program: Recommendations and Lessons Learned. The report analyzes some of the costs and benefits of law enforcement using body-worn video technology.



  • OPA Press Releases

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Wisconsin Pharmacist and Nevada Pharmacologist Charged with Smuggling Counterfeit Pharmaceuticals Using a Costa Rican Internet Pharmacy

A Wisconsin pharmacist and a Nevada pharmacologist were arraigned on an indictment today in Federal Court in Central Islip, New York, before United States Magistrate Judge Gary Brown. The defendants are charged with conspiring to supply at least four million misbranded and counterfeit pharmaceuticals to an illegal Internet pharmacy based in Costa Rica that catered to U.S. customers.



  • OPA Press Releases

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Justice Department and CNCS Announce $1.8 Million in Grants to Enhance Immigration Court Proceedings and Provide Legal Assistance to Unaccompanied Children

The Department of Justice and the Corporation for National and Community Service (CNCS), which administers AmeriCorps national service programs, has awarded $1.8 million in grants to increase the effective and efficient adjudication of immigration proceedings involving certain children who have crossed the U.S. border without a parent or legal guardian.



  • OPA Press Releases

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Attorney General Holder Announces Pilot Program to Counter Violent Extremists

Attorney General Eric Holder announced Monday that the Justice Department will launch a new series of pilot programs in cities across the country to bring together community representatives, public safety officials and religious leaders to counter violent extremism. The new programs will be run in partnership with the White House, the Department of Homeland Security, and the National Counterterrorism Center.



  • OPA Press Releases

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Episcopal Ministries to the Aging Inc. to Pay $1.3 Million for Allegedly Causing Submission of Claims for Unreasonable or Unnecessary Rehabilitation Therapy at Skilled Nursing Facility

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.



  • OPA Press Releases

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U.S. Settlement with Michigan Utility to Reduce Emissions at Its Coal-Fired Power Plants, Fund Projects to Benefit Environment and Communities

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.



  • OPA Press Releases

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Detroit-Area Doctor Admits to Providing Medically Unnecessary Chemotherapy to Patients

A Detroit-area hematologist-oncologist pleaded guilty today for his role in a health care fraud scheme, admitting that he administered unnecessary chemotherapy to fraudulently bill the Medicare program and private insurance companies. According to court records, the scheme enabled the doctor to submit approximately $225 million in claims to Medicare over six years.



  • OPA Press Releases

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Attorney General Holder Announces Partnership with Department of Housing and Urban Development to Improve Civil Legal Aid for Juveniles

Attorney General Eric Holder is set to announce a partnership between the Department of Justice’s Office of Juvenile Justice and Delinquency Prevention (OJJDP) and the Department of Housing and Urban Development (HUD). HUD will offer new grants to support collaborations between HUD-funded organizations, and civil legal aid programs and public defender offices. The grant funded collaborations will focus on expunging and sealing juvenile records – improving the chances that reentering youth will be able to obtain degrees, find work and secure housing. The announcement is set to be made this evening during the Attorney General’s remarks to the Legal Services Corporation 40th anniversary celebration.



  • OPA Press Releases

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Hawaii Man Sentenced to 87 Months Imprisonment for Communicating Classified National Defense Information to Unauthorized Person

Benjamin Pierce Bishop, 60, a former Honolulu, Hawaii, civilian defense contractor and retired lieutenant colonel in the U.S. Army, was sentenced today by U.S. District Judge Leslie E. Kobayashi to serve 87 months imprisonment and three years’ supervised release for willfully communicating classified national defense information to a person not authorized to receive it and unlawfully retaining classified national defense information at his home.



  • OPA Press Releases

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Remarks by Assistant Attorney General for the Criminal Division Leslie R. Caldwell at the Taxpayers Against Fraud Education Fund Conference

Qui tam cases are a vital part of the Criminal Division’s future efforts. We encourage you to reach out to criminal authorities in appropriate cases, even when you are discussing the case with civil authorities. The sooner we on the criminal side learn about potential criminal conduct, the sooner we can investigate.




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Justice Department Announces National Effort to Build Trust Between Law Enforcement and the Communities They Serve

Attorney General Eric Holder announced today the launch of the Justice Department’s National Initiative for Building Community Trust and Justice.



  • OPA Press Releases

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Service Members to Receive Over $123 Million for Unlawful Foreclosures Under the Servicemembers Civil Relief Act

The Justice Department announced today that under its settlements with five of the nation’s largest mortgage servicers, 952 service members and their co-borrowers are eligible to receive over $123 million for non-judicial foreclosures that violated the Servicemembers Civil Relief Act (SCRA)



  • OPA Press Releases

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Deutsche Bank's London Subsidiary Agrees to Plead Guilty in Connection with Long-Running Manipulation of LIBOR

DB Group Services (UK) Limited, a wholly owned subsidiary of Deutsche Bank AG (Deutsche Bank), has agreed to plead guilty to wire fraud for its role in manipulating the London Interbank Offered Rate (LIBOR), a leading benchmark interest rate used in financial products and transactions around the world



  • OPA Press Releases

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Deputy Attorney General Sally Quillian Yates Delivers Remarks at New York University School of Law Announcing New Policy on Individual Liability in Matters of Corporate Wrongdoing

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




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Deputy Attorney General Sally Quillian Yates Delivers Remarks at American Banking Association and American Bar Association Money Laundering Enforcement Conference

Remarks as prepared for delivery

Thank you, Buddy [Wilmer Parker], for that kind introduction




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Former SunTrust Mortgage VP and Loan Officers Sentenced to Prison

ALEXANDRIA, Va



  • OPA Press Releases

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Two Former Deutsche Bank Employees Indicted on Fraud Charges in Connection with Long-Running Manipulation of Libor

Two former Deutsche Bank AG (Deutsche Bank) traders—the bank’s supervisor of the Pool Trading Desk in New York and a derivatives trader in London—were indicted for their alleged roles in a scheme to manipulate the U



  • OPA Press Releases

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Former Loudoun County Sheriff’s Deputy Sentenced to Prison

ALEXANDRIA, Va



  • OPA Press Releases

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SAVA Gets Funding For AD Drug, JNJ Hits All-time High, ENZ On Watch

Today's Daily Dose brings you news about Cassava Sciences' research grant from the National Institutes of Health for developing Alzheimer's disease drug; Edwards Lifesciences' Q1 financial results; Enzo Biochem's launch of the next-generation COVID-19 test kits and Johnson & Johnson's deal with Emergent BioSolutions related to COVID-19 Vaccine candidate.




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Junshi, Eli Lilly Agree To Co-develop JS016 Antibodies Against COVID-19

Junshi Biosciences, a China-based biopharmaceutical company, and Eli Lilly and Company (LLY) have entered into an agreement to co-develop therapeutic antibodies for the potential prevention and treatment of COVID-19. Junshi SARS-CoV-2 Antibodies, or JS016, is a recombinant fully human monoclonal neutralizing antibody that is specific to the SARS-CoV-2 surface spike protein receptor binding domain. It is jointly developed by Junshi Biosciences and Institute of Microbiology, Chinese Academy of Science.




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Ocean Spray Recalls Pink Lite Cranberry Juice For Undeclared Sulfites

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




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Medifast Recalls Optavia Oatmeal For Undeclared Milk

Baltimore, Maryland-based Medifast, Inc. is recalling certain Optavia Oatmeal products citing undeclared milk, a known allergen, the U.S. Food and Drug Administration said in a statement. The recall involves around 24,923 boxes of OPTAVIA Essential Old Fashioned Maple & Brown Sugar Oatmeal. The product is packaged in yellow and white cardboard boxes with the brand name.




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How States and Counties Can Help Individuals With Opioid Use Disorder Re-Enter Communities

At least 95 percent of individuals in state prisons will eventually return to communities. In fact, in a typical year more than half a million people do so, with many more coming from jails. A disproportionate share of these individuals have one or more chronic illnesses.




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Coronavirus Testing Delays in the United States: What Happened?

Testing for the novel coronavirus in the United States has not kept pace with the enormous demand despite national efforts to ramp up capacity.




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The Promise Of Precision Neuroscience And Launch Of Arkuda Therapeutics

Neuroscience has had a tough run of news lately. With Amgen deprioritizing neuro this year, Pfizer doing the same last year, and others like BMS, GSK, and AZ cutting back on CNS a few years earlier, it would seem dark

The post The Promise Of Precision Neuroscience And Launch Of Arkuda Therapeutics appeared first on LifeSciVC.




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Running Rehab: Managing Talent In A Pandemic

This blog was written by Andrea DiMella, VP and Head of Talent at Atlas Venture, as part of the From The Trenches feature of LifeSciVC. What a difference a little time makes. When Bruce originally encouraged me to be a

The post Running Rehab: Managing Talent In A Pandemic appeared first on LifeSciVC.




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BASF Launches Breakthrough Absorption Technology as GOED Raises Bioavailability Challenge to Omega-3 Industry

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.




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Probi's Largest Clinical Trial Confirms the Immune Enhancing Impact of Probi Defendum®

Probi's largest clinical trial ever, focused on probiotic immune health, has recently been completed.




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New Study with Wellmune Shows Promise for Intestinal Barrier Function Improvements

A study demonstrated Wellmune® may protect intestinal barrier function in adults when faced with stress.




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innoVactiv Inc. Announces the Publication of Positive Cognition Study Results for InSea2®

innoVactiv announces today its study supporting the efficacy of InSea2® to beneficially affect post-meal cognition and mental energy has been accepted for publication.




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'Doctor' Tony Huge: Brand Ambassador or Founder/Boss of Enhanced Athlete?

New Legal Motion Challenges Tony Huge’s Supposed Unpaid Role in Enhanced Athlete




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Ingredient Manufacturer Announces Non-GMO Project Verified Caffeine Ingredient

Applied Food Sciences, Inc. (AFS) takes the next step in demonstrating complete transparency by getting four of its core ingredients Non-GMO Project Verified.




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National Institutes of Health Announces NIAGEN® Shows Improved Cognitive and Physical Function

ChromaDex Corp. announced NIAGEN® nicotinamide riboside prevented neurological damage and improved cognitive and physical function in a new mouse model of Alzheimer’s disease.




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CRN Launches #SARMsCanHarm Consumer Education Initiative to Raise Awareness of SARMs Dangers

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.




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A Thoughtful Innovation: HP Ingredients Launches Quantum IQ for Cognitive Health

The cognitive-boost market just received another potent supplement ingredient–Quantum IQ Polygonum minus extract, exclusively from HP Ingredients, Inc. (HPI).




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Sunlight exposure and its role in skin-gut axis

Outside influences have shown strong correlations with what lives inside our bodies, and researchers are just beginning to understand how these environmental factors may affect the makeup of the gut microbiome.




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Immunity products: "This is the world's biggest ever advertising campaign, bar none"

It is "inconceivable" that immunity will not remain high on the list of health priorities when this pandemic ends and now is the time to create more "convincing experiences" to ensure trial turns into adoption, according to food and drink research and branding experts.



  • Markets and Trends

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Active nutrition and immunity: Getting the right balance

Exercise is good for the immune system but, as with anything, balance is key and this is especially the case when it comes to matching the type and level of activity with the right nutrition, as will be expertly explained in NutraIngredients' upcoming webinar.




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NutraIngredients to announce 2020 award winners online

NutraIngredients is pleased to announce the shortlisted finalists for the 2020 edition of the NutraIngredients Awards ... with the winners to be announced in the first online awards ceremony next week (May 13th).




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Promoting Universal Health Coverage: Sharing a Prosperous and Healthy Future

Leaders from around the world gathered at the United Nations General Assembly in New York on 23 September for the first-ever United Nations High-Level Meeting (UNHLM) on Universal Health Coverage (UHC): Moving Together to Build a Healthier World.




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Finalists of APEC Healthy Women, Healthy Economy Prize Announced

Equal pay, migrant workers, and maternal health are the issues highlighted by the finalists of the inaugural APEC Healthy Women, Healthy Economies Research Prize.




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Inaugural Healthy Women Health Economies Prize Announces Winning Research

A comprehensive study on the health needs of Filipino migrant workers has won the inaugural APEC Healthy Women Healthy Economies award.




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Structural Reforms Can Counter Slower Growth Across APEC

Structural reforms can counter slower economic growth in the Asia-Pacific region, says a new report by the APEC Policy Support Unit.




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APEC Announces Postponement of Upcoming Ministerial Meetings

Malaysia, the host of APEC 2020, has announced the postponement of the upcoming Second Senior Officials’ Meeting, the 2020 APEC Tourism Ministerial Meeting, and the 2020 APEC Ministers Responsible of Trade Meeting, which were scheduled for April this year.




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RE: UDI Requirements under an Emergency Use Authorization

From : Communities>>Regulatory Open Forum
I disagree with Richard. I just had a conversation with the COVID-19 hotline (11:45 am, May 7) and asked about this issue after having read an update from the FDA that said UDIs for EUA devices are waived and GMPs are under limited enforcement. The person I spoke with said the update is correct and that UDIs are waived for EUA devices.  Feel free to contact me if you have any questions.  Bob Bard ------------------------------ Robert Bard JD, RAC [Managing Director] South Lyon MI United States - [More]




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Draft 2020 Chinese pharmacopeia includes hundreds of new pharmaceuticals

From : Communities>>Regulatory Open Forum
Hi everyone, As currently drafted,  the 2020 Chinese Pharmacopeia, the benchmark publication on the safety and efficacy of pharmaceuticals legally available in China, includes 319 new entries. The publication includes more than 5,500 traditional Chinese and Western medicines. The official compendium of the standards of purity, description, test, dosage, precaution, storage, and the strength for each drug legally marketed in China is published by the Chinese Pharmacopoeia Commission. It is designed [More]




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Online sale of unapproved combinations of Minoxidil as topical solution

From : Communities>>Regulatory Open Forum
Hello,  I can see many unapproved combinations of Minoxidil as topical solution like minoxidil+ Azelaic Acid; Minoxidil + Finasteride; Minoxdil+ niacin+retinol+caffeine that are available online for sale in US but these drug products are not approved by FDA as visble from USFDA website.  Can anyone explain that is there any mechanism or guideline to allows to sell such unapproved drug products online in US and also in EU? Or is this totally illegal practice?  Thanks Ankur RAC




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RE: UDI Requirements under an Emergency Use Authorization

From : Communities>>Regulatory Open Forum
Bob, I stand corrected; if you confirmed with FDA that is good.  From what I was reading and seeing (I must have missed that update) there was nothing addressing UDI or no UDI.for EUA products.  (Personally I am a bit surprised at this since the whole concept of UDI is traceability and they waive this for emergency use products - when there is an issue this is where UDI becomes so important.  Shrugs.) ------------------------------ Richard Vincins RAC Vice President Global Regulatory Affairs --- [More]




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RE: Online sale of unapproved combinations of Minoxidil as topical solution

From : Communities>>Regulatory Open Forum
Hi, Ankur - Some may be "legal," others not. It's a big industry, and it is fair to be cynical. Combination products for sale that have not been approved-as the combination-by FDA are just that, unapproved drugs. I assume you checked for the approval status in FDA's "Orange Book" (https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm). Even if both active pharmaceutical ingredients in a 2-drug mixture were approved separately on their own, it does not mean the combined product is approved for [More]