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New Jersey Man Pleads Guilty to Operating Fraudulent Visa and Payroll Scheme to Facilitate Illegal Immigration

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.



  • OPA Press Releases

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Former Alabama Sheriff’s Investigator Sentenced to 36 Months for Assaulting Handcuffed Man at Macon County Jail

J. Keith McCray, previously a criminal investigator with the Macon County, Alabama, Sheriff’s Office, was sentenced today by Judge Myron H. Thompson to serve 36 months in prison and two years of supervised release for assaulting a handcuffed man at the county jail, announced the Justice Department and the U.S. Attorney’s Office for the Middle District of Alabama.



  • OPA Press Releases

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Former TierOne Bank Executive Pleads Guilty for His Role in Scheme to Defraud Bank’s Shareholders and Regulators

A former senior vice president and chief credit officer of TierOne Bank, a publicly traded commercial bank formerly headquartered in Lincoln, Nebraska, pleaded guilty today for his role in a scheme to defraud TierOne’s shareholders and regulators.



  • OPA Press Releases

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Arvada Woman Pleads Guilty to Conspiracy to Provide Material Support to a Designated Foreign Terrorist Organization

Shannon Conley, age 19, of Arvada, Colorado, pleaded guilty this morning before U.S. District Court Judge Raymond P. Moore to one count of conspiracy to provide material support to a designated foreign terrorist organization, U.S. Attorney John Walsh for the District of Colorado and Special Agent in Charge Thomas Ravenelle of the FBI Denver Division announced. Conley is scheduled to be sentenced by Judge Moore on January 23, 2015. The defendant appeared at the change of plea hearing in custody, and was remanded at its conclusion.



  • OPA Press Releases

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Owner of Tax Return Preparation Franchise and Health Provider Business Sentenced to Prison for Tax Fraud, Healthcare Fraud and Money Laundering

Claude Arthur Verbal II, formerly of Raleigh, North Carolina, and now of Miami, was sentenced today to serve 135 months in prison for tax fraud, healthcare fraud and money laundering crimes in two separate cases in federal court



  • OPA Press Releases

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Hewlett-Packard Russia Pleads Guilty to and Sentenced for Bribery of Russian Government Officials

ZAO Hewlett-Packard A.O. (HP Russia), an international subsidiary of the California technology company Hewlett-Packard Company (HP Co.), pleaded guilty today to felony violations of the Foreign Corrupt Practices Act (FCPA) and was then sentenced for bribing Russian government officials to secure a large technology contract with the Office of the Prosecutor General of the Russian Federation.



  • OPA Press Releases

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Alabama Man Pleads Guilty to Threatening African-American Man and a Restaurant Manager

Jeremy Heath Higgins, 28, a resident of Quinton, Alabama, pleaded guilty today before U.S. District Judge Madeline Haikala to two counts of federal civil rights violations, announced the Justice Department’s Civil Rights Division and the U.S. Attorney’s Office for the Northern District of Alabama.



  • OPA Press Releases

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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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Owner of Costa Rican Call Center Pleads Guilty to Defrauding Elderly Through Sweepstakes Scam

A dual United States-Costa Rican citizen pleaded guilty today for his role in a $1.88 million sweepstakes fraud scheme that defrauded hundreds of elderly Americans.



  • OPA Press Releases

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Ambulance Company Manager Pleads Guilty to $5.5 Million Medicare Fraud Conspiracy

The general manager of a Southern California ambulance company pleaded guilty yesterday in Los Angeles to conspiracy to commit Medicare fraud, conspiracy to obstruct a Medicare audit, and making materially false statements to law enforcement officers.



  • OPA Press Releases

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Pennsylvania Man Pleads Guilty in Conspiracy to Illegally Export Restricted Laboratory Equipment to Syria

U.S. Attorney Peter Smith for the Middle District of Pennsylvania, Special Agent in Charge John Kelleghan for Philadelphia, U.S. Immigration and Customs Enforcement’s (ICE) Homeland Security Investigations (HSI) and Special Agent in Charge Sidney M. Simon of the New York Field Office, Office of Export Enforcement, U.S. Department of Commerce announced that yesterday Harold Rinko, 72, of Hallstead, Pennsylvania, appeared before Senior District Court Judge Edwin M. Kosik in Scranton and pleaded guilty to conspiracy to illegally export laboratory equipment, including items used to detect chemical warfare agents, from the United States to Syria, in violation of federal law



  • OPA Press Releases

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Florida Home Health Care Company and Its Owners Agree to Resolve False Claims Act Allegations for $1.65 Million

A Plus Home Health Care Inc. and its owners, Tracy Nemerofsky and her father, Stephen Nemerofsky, have agreed to pay $1.65 million to the United States to settle allegations that A Plus paid spouses of referring physicians for sham marketing positions in order to induce patient referrals.



  • OPA Press Releases

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Alabama Real Estate Investor Pleads Guilty to Conspiracy to Commit Mail Fraud

An Alabama real estate investor pleaded guilty yesterday for his role in a conspiracy to commit mail fraud related to public real estate foreclosure auctions held in southern Alabama, the Department of Justice announced today



  • OPA Press Releases

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Northern California Real Estate Investor Agrees to Plead Guilty to Bid Rigging and Fraud at Public Foreclosure Auctions

A Northern California real estate investor has agreed to plead guilty for his role in conspiracies to rig bids and commit mail fraud at public real estate foreclosure auctions in Northern California, the Department of Justice announced



  • OPA Press Releases

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Northern California Real Estate Investor Agrees to Plead Guilty to Bid Rigging and Fraud Conspiracies at Public Foreclosure Auctions

A Northern California real estate investor has agreed to plead guilty for his role in bid rigging and fraud conspiracies at public real estate foreclosure auctions in Northern California, the Department of Justice announced



  • 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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Former Owner of Empire Towers Pleads Guilty for Fraudulent $7 Million Bond Scheme and Filing False Tax Return

Misled More Than 50 Individual Investors Who Bought Bonds

A former Queenstown, Maryland, resident pleaded guilty today to securities fraud and filing a false tax return



  • OPA Press Releases

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Father Of Former Investment Bank Managing Director Pleads Guilty To Insider Trading Conspiracy

Preet Bharara, the United States Attorney for the Southern District of New York, announced that ROBERT STEWART, the father of former investment bank managing director Sean Stewart, pled guilty today to participating in a conspiracy to trade on inside information about several mergers and acquisitions announced between 2011 and 2014



  • OPA Press Releases

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Real Estate Investor Pleads Guilty to Bid Rigging and Fraud Conspiracies at Georgia Public Foreclosure Auctions

A Georgia real estate investor pleaded guilty today for his role in conspiracies to rig bids and commit mail fraud at public real estate foreclosure auctions in Fulton and DeKalb counties, Georgia



  • OPA Press Releases

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Former California Attorney Pleads Guilty in International Investment Fraud Scheme

A Las Vegas man pleaded guilty today to conspiracy for his role in an investment fraud scheme that promoted fraudulent investment opportunities and caused more than $5 million in losses to investors



  • OPA Press Releases

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Morgan Stanley Agrees to Pay $2.6 Billion Penalty in Connection with Its Sale of Residential Mortgage Backed Securities

The Justice Department today announced that Morgan Stanley will pay a $2



  • OPA Press Releases

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Former Postal Clerk Pleads Guilty to Stealing Mail

NORFOLK, Va



  • OPA Press Releases

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New York Man Pleads Guilty to Conspiracy to Defraud U.S. Defense Contractors

ALEXANDRIA, Va



  • OPA Press Releases

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Former Fox News Commentator Pleads Guilty to Fraud

ALEXANDRIA, Va



  • OPA Press Releases

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Alexandria Adult Day Healthcare Center Settles Civil Fraud Allegations

ALEXANDRIA, Va



  • OPA Press Releases

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Toano Man Pleads Guilty to Impersonating a Federal Agent

NEWPORT NEWS, Va



  • OPA Press Releases

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Former Nurse Pleads Guilty to ID Theft and Bank Fraud

RICHMOND, Va



  • OPA Press Releases

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New FDA guidance on alternate approaches in premarket notification for Class II medical devices

By Alice Li, MD, MSc, RAC (CAN), Regulatory Scientist, Cato Research FDA issued “The Abbreviated 510(k) Program – Guidance for Industry and Food and Drug Administration Staff” on 13 September 2019. The content of this guidance supersedes the content from 1998 guidance “The New 510(k) Paradigm – Alternate Approaches to Demonstrating Substantial Equivalence in Premarket …

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What’s New Health Canada? November 2019 Updates

By Alejandra Gomez Perez, M.Sc., Regulatory Affairs Associate   What’s New in: Therapeutic Products Directorate: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/what-new-drug-products-health-canada.html Biologics and Genetic Therapies Directorate: http://www.hc-sc.gc.ca/dhp-mps/brgtherap/update-miseajour/index-eng.php Medical Devices: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/what-new.html Natural and Non-prescription Health Products Directorate: https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/what-new.html   Updates from Health Canada Type of Update and Link Date Posted Notice – Update to Clinical Trial Site Information Form 29 November …

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What’s New Health Canada? January and February 2020 Updates

  By Alejandra Gomez Perez, M.Sc., Regulatory Affairs Associate   What’s New in:   Therapeutic Products Directorate: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/what-new-drug-products-health-canada.html Biologics and Genetic Therapies Directorate: http://www.hc-sc.gc.ca/dhp-mps/brgtherap/update-miseajour/index-eng.php Medical Devices: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/what-new.html Natural and Non-prescription Health Products Directorate: https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/what-new.html   Updates from Health Canada   Type of Update and Link Date Posted Notice: Product Monograph Implementation Plans 13 January 2020 …

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What’s New Health Canada?

By Alejandra Gomez Perez, M.Sc., Regulatory Affairs Associate   What’s New in: Therapeutic Products Directorate: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/what-new-drug-products-health-canada.html Biologics and Genetic Therapies Directorate: http://www.hc-sc.gc.ca/dhp-mps/brgtherap/update-miseajour/index-eng.php Medical Devices: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/what-new.html Natural and Non-prescription Health Products Directorate: https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/what-new.html   Updates from Health Canada   New Private Label Medical Device Licence Application Form 07 April 2020 Guidance Document: How to Complete the …

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Avadel (AVDL) Soars On REST-ON Trial Results

Avadel Pharmaceuticals plc's (AVDL) pivotal phase III trial evaluating FT218 for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy has met its three co-primary efficacy endpoints at all three doses.




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HIAs and Other Resources to Advance Health-Informed Decisions

The Health Impact Project’s toolkit contains resources that help communities, agencies, and other organizations take action to improve public health. The toolkit offers a collection of health impact assessments, guides, and other research to support policymakers’ efforts to consider health when making decisions across sectors, such as housing, planning, and education.




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Six Ways New Federal Health IT Rules Improve Both Care and Public Health

The federal government in March released a pair of long-awaited rules that will give patients greater access to their health data and improve the flow of information across care settings.




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Some Indicators of Public Health in Philadelphia Had Improved Before COVID-19

The spread of COVID-19 is placing unprecedented strain on Philadelphia’s hospitals, public health systems, and residents. Although the full effects of the emergency have yet to be realized, newly released data from 2018 and 2019 provides insight on the state of public health in the city before the pandemic.




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Pew Urges Congress to Promote Patient Matching in Electronic Health Records to Address COVID-19

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.




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The Health Care Practitioner Channel: Connecting Industry and Medical Professionals

Selling directly to health care practitioners, supplement companies can foster open dialogue about their products; but, every regulation applies to products in this channel, too.




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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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Organic Trade Association and The Organic Center Applaud Senate Bill, Organic Agriculture Research

The Organic Trade Association and The Organic Center on Thursday applauded Senators Bob Casey (D-PA) and Susan Collins (R-ME) for introducing The Organic Agriculture Research Act of 2018.




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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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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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Study: Eating almonds may help lower CVD risk factors and associated healthcare costs

A recent study conducted by researchers at Tufts University suggests that consuming 1.5 ounces of almonds per day, compared to no almond consumption, may help reduce CVD risk factors such as elevated LDL cholesterol levels, and as a result, reduce an individual's healthcare costs associated with treating such conditions.




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Chile Joins APEC Efforts to Bolster Health Ethics, Support SMEs and Patients

APEC continues to bolster ethics in the healthcare sector in support of small and medium enterprises (SMEs) and patients, as Chile launches a consensus framework to improve ethical interactions in its healthcare system.




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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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APEC Healthy Women Prize Accepting Applications

Research Promoting Women’s Health to Receive $20,000 Prize




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APEC Health Working Group Statement on COVID-19

Reflecting the discussions of the Health Working Group which met at the First APEC Senior Officials Meeting, 7-8 February 2020, Putrajaya, Malaysia




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RE: Guidance for off-label use of medical devices in Canada (Health Canada)?

From : Communities>>Regulatory Open Forum
Thank you Dinar! ------------------------------ MARIA GUDIEL Brea CA United States ------------------------------




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RE: Guidance for off-label use of medical devices in Canada (Health Canada)?

From : Communities>>Regulatory Open Forum
Thank you Richard! ------------------------------ MARIA GUDIEL Brea CA United States ------------------------------