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Former Subway Franchise Owner Pleads Guilty to Gift Card Hacking Scheme at Subway Restaurants

A California man pleaded guilty today in the District of Massachusetts for his role in a conspiracy to hack into the computerized cash registers of a number of Subway restaurants to fraudulently obtain more than $40,000 in gift cards.



  • OPA Press Releases

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Four Ohio Businessmen Associated with Cadillac Ranch Restaurants Plead Guilty to Tax Charges

Four businessmen involved in the development, operation and ownership of restaurants, including Cadillac Ranch restaurants, in Ohio and elsewhere in the United States, pleaded guilty today to tax charges, the Justice Department and Internal Revenue Service announced.



  • OPA Press Releases

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Former Utah Certified Public Accountant Convicted of Filing False Claims for Tax Refunds Totaling More Than $8 Million and Presenting a $300 Million Fictitious Financial Instrument

Dick Reid Jenkins, of Heber City, Utah, was convicted today, in U.S. District Court for the District of Utah, of eighteen counts of filing false claims for income tax refunds and one count of presenting a fictitious financial instrument, the Justice Department and Internal Revenue Service (IRS) announced.



  • OPA Press Releases

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District Court Approves Selection of Arnaldo Claudio as Technical Compliance Advisor to Oversee Critical Reforms of Puerto Rico Police Department

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.



  • OPA Press Releases

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Justice Department and CNCS Announce New Partnership to Enhance Immigration Courts and Provide Critical Legal Assistance to Unaccompanied Minors

The Corporation for National and Community Service (CNCS), which administers AmeriCorps, and the Department of Justice today announced “justice AmeriCorps,” a strategic partnership to increase national service opportunities while enhancing 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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Houston Ambulance Operator Sentenced for Her Role in $2.4 Million Health Care Fraud Scheme

The owner and operator of a Houston area ambulance company was sentenced today to serve 97 months in prison for her role in a $2.4 million Medicare fraud scheme



  • OPA Press Releases

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Justice Department and Consumer Financial Protection Bureau Reach $169 Million Settlement to Resolve Allegations of Credit Card Lending Discrimination by GE Capital Retail Bank

The Department of Justice and the Consumer Financial Protection Bureau (CFPB) today announced a settlement to resolve allegations that GE Capital Retail Bank, known as of this month as Synchrony Bank, engaged in a nationwide pattern or practice of discrimination by excluding Hispanic borrowers from two of its credit card debt-repayment programs



  • OPA Press Releases

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Joint Statement from the Office of the Director of National Intelligence and the Department of Justice on the Declassification of Renewal of Collection Under Section 501 of the Foreign Intelligence Surveillance Act

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



  • OPA Press Releases

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Department of Justice and Office of the Director of National Intelligence Announce Declassification of Renewal of Collection Under Section 501 of the Foreign Intelligence Surveillance Act

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



  • OPA Press Releases

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BNP Paribas Agrees to Plead Guilty and to Pay $8.9 Billion for Illegally Processing Financial Transactions for Countries Subject to U.S. Economic Sanctions

According to court documents submitted today, BNP Paribas S.A. (BNPP), a global financial institution headquartered in Paris, agreed to enter a guilty plea to conspiring to violate the International Emergency Economic Powers Act (IEEPA) and the Trading with the Enemy Act (TWEA) by processing billions of dollars of transactions through the U.S. financial system on behalf of Sudanese, Iranian, and Cuban entities subject to U.S. economic sanctions



  • OPA Press Releases

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BNP Paribas Pleads Guilty to Conspiring to Violate U.S. Economic Sanctions in Manhattan Federal Court

BNP Paribas S.A. (BNPP), a global financial institution headquartered in Paris, pleaded guilty today before U.S. District Judge Lorna G. Schofield in the Southern District of New York to a one-count information charging the bank with conspiring to violate the International Emergency Economic Powers Act (IEEPA) and the Trading with the Enemy Act (TWEA), for its role in processing billions of dollars of U.S. dollar transactions through the U.S. financial system on behalf of Sudanese, Iranian, and Cuban entities subject to U.S. economic sanctions from 2004 through 2012



  • OPA Press Releases

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U.S. Branch of Canadian Company to Pay $2.5 Million Penalty for Shreveport, La., Wastewater Plant

Houston-based CCS (USA) Inc. and several of its operating subsidiaries will pay a $2.5 million civil penalty relating to operations at its Shreveport, Louisiana, industrial wastewater treatment plant, the Department of Justice, U.S. Environmental Protection Agency (EPA) and the state of Louisiana announced today. The settlement will resolve violations of the Clean Water Act, the Clean Air Act and the hazardous waste law known as RCRA



  • OPA Press Releases

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Attorney General Holder Speaks at Press Conference Announcing Major Financial Fraud

"Citi is not the first financial institution to be held accountable by this Justice Department, and it will certainly not be the last. In the investigations that remain open, we will continue to move forward – guided by the facts and the law – to achieve justice for those affected by the financial crisis."




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Happy’s Pizza Franchise Owner and Nominee Owner Plead Guilty in Tax Fraud Scheme

Two West Bloomfield, Michigan, residents pleaded guilty in the U.S. District Court for the Eastern District of Michigan today, announced the Justice Department and Internal Revenue Service (IRS).



  • OPA Press Releases

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Historic Clean Water Act Settlement Will Prevent Millions of Gallons of Sewage Discharges into San Francisco Bay

The U.S. Environmental Protection Agency today announced a Clean Water Act settlement requiring the East Bay Municipal Utility District (EBMUD) and seven East Bay communities to conduct extensive system repairs aimed at eliminating millions of gallons of sewage discharges into San Francisco Bay. Under today’s agreement, EBMUD and the communities will assess and upgrade their 1,500 mile-long sewer system infrastructure over a 21-year period



  • OPA Press Releases

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Texas Resident Charged with Tax Fraud and Financial Institution Fraud

A Texas woman who was the manager of a North Carolina tax preparation business was indicted today for multiple tax crimes and making false statements to banks on loan applications, the Justice Department and Internal Revenue Service (IRS) announced



  • OPA Press Releases

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Connecticut Insurance Salesman Indicted on Tax Charges

A Newington, Connecticut, man was indicted last Thursday by a grand jury in the District of Connecticut for one count of corruptly interfering with the due administration of the internal revenue laws, two counts of filing false tax returns and five counts of willfully failing to file tax returns, the Justice Department and Internal Revenue Service (IRS) announced



  • OPA Press Releases

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Bank of America to Pay $16.65 Billion in Historic Justice Department Settlement for Financial Fraud Leading up to and During the Financial Crisis

Attorney General Eric Holder and Associate Attorney General Tony West announced today that the Department of Justice has reached a $16.65 billion settlement with Bank of America Corporation – the largest civil settlement with a single entity in American history ­— to resolve federal and state claims against Bank of America and its former and current subsidiaries, including Countrywide Financial Corporation and Merrill Lynch. As part of this global resolution, the bank has agreed to pay a $5 billion penalty



  • OPA Press Releases

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Attorney General Holder Delivers Remarks at Press Conference Announcing Major Financial Fraud

"We are here to announce a historic step forward in our ongoing effort to protect the American people from financial fraud – and to hold accountable those whose actions threatened the integrity of our financial markets and undermined the stability of our economy."




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Associate Attorney General West Delivers Remarks at Press Conference Announcing Major Financial Fraud

"Yet in addition to accountability, this historic resolution is also significant for what it achieves in terms of restoration: it requires those we are holding accountable to shoulder some of the responsibility for repairing the damage caused by their conduct."




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Philadelphia Political Consultant Pleads Guilty for His Role in Attempting to Conceal Campaign Finance-Related Fraud

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



  • OPA Press Releases

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Former Maryland Resident Sentenced for His Role in $3.7 Million Advance Fee Scheme and Tax Evasion

A Corona, California, man was sentenced today to serve six years in prison to be followed by three years of supervised release in connection with a fraudulent advance fee scheme and tax evasion.



  • 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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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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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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Attorney General Holder Remarks on Financial Fraud Prosecutions at NYU School of Law

Thank you, Professor [Jennifer] Arlen, for those kind words – and thank you all for being here. It’s a privilege to be at New York University this afternoon




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Justice Department and State Partners Secure $1.375 Billion Settlement with S&P for Defrauding Investors in the Lead Up to the Financial Crisis

Attorney General Eric Holder announced today that the Department of Justice and 19 states and the District of Columbia have entered into a $1.375 billion settlement agreement with the rating agency Standard &s Financial Services LLC, along with its parent corporation McGraw Hill Financial Inc., to resolve allegations that S&s 2013 lawsuit against S& true credit risks. Other allegations assert that S&s business relationships with the investment banks that issued the securities.



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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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New FDA Guidances for November and December 2019 and Upcoming Advisory Committee Meetings

By Alice Li, MD, MSc, RAC(CAN), Regulatory Scientist, Cato Research Special Interest Guidances/Information Date Posted Guidance for Industry: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion, Reference Amounts Customarily Consumed, Serving Size-Related Issues, Dual-Column Labeling, and Miscellaneous Topics – Final Guidance 30 Dec 2019 Submission of Plans for Cigarette Packages …

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New FDA Gudiances for January 2020 and Upcoming Advisory Committee Meetings

By Sheila Plant, PhD, MHS, RAC, Senior Director, Regulatory Strategy, CATO SMS Special Interest Guidances/Information Date Posted Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components; Draft Guidance for Industry: Draft Guidance for Industry – Draft Guidance 30 Jan 2020 Arthroscopy Pump Tubing Sets …

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New FDA Gudiances for February 2020 and Upcoming Advisory Committee Meetings

By Sheila Plant, PhD, MHS, RAC, Senior Director, Regulatory Strategy, CATO SMS    Special Interest Guidances/Information Date Posted Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency: Immediately in Effect Guidance for Clinical Laboratories and Food and …

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New FDA Gudiances for March 2020 and Upcoming Advisory Committee Meetings

By Sheila Plant, PhD, MHS, RAC, Senior Director, Regulatory Strategy, CATO SMS FDA guidances from March 2020 as well as upcoming advisory committee meeting announcements are below.  We note that approximately one-third of FDA’s guidances this past month are related to COVID-19.    Special Interest Guidances/Information Date Posted Enforcement Policy for Gowns, Other Apparel, and …

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New FDA Gudiances for April 2020 and Upcoming Advisory Committee Meetings

By Zachary Swan, PhD, RAC, Associate Director, Regulatory Affairs at CATO SMS    Special Interest Guidances/Information Date Posted Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency: Guidance for Industry – Final Guidance 30 April 2020 FDA Deems Certain Tobacco Products Subject to FDA Authority, …

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Axsome Therapeutics (AXSM) Advances To Cross $100-Mark

Axsome Therapeutics Inc.'s (AXSM) phase II/III trial of investigational drug AXS-05 in Alzheimer's disease agitation has met the primary endpoint.




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Sutro Biopharma Reports Updated Data From Ovarian Cancer Study

Sutro Biopharma Inc.'s (STRO) interim phase I updated clinical data for a dose-escalation study of antibody drug-conjugate STRO-002 in ovarian cancer has been encouraging.




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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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Care Coordination Strategies for Patients Can Improve Substance Use Disorder Outcomes

Care coordination is considered a hallmark of patient-centered treatment and has been shown to improve health outcomes and patient satisfaction as well as reduce costs. Defined as organizing patient care activities and sharing information among all participants concerned with an individual’s treatment plan in order to achieve safer and more effective results, care coordination is increasingly...




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Why Words Matter in the Substance Use Conversation

In any public health or policy issue, it is important to consider the language used to discuss the people affected. The nation’s prolonged opioid crisis continues to touch many communities and families, and the way in which experts and others talk about substance use disorders, their causes, and the solutions is evolving.




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The Balancing Act: Taking A Systematic Approach To Hard Decisions In Times Of Rapid Change

This blog was written by Ankit Mahadevia, CEO of Spero Therapeutics, as part of the From The Trenches feature of LifeSciVC.  If CEOs have empowered their teams effectively, they have three roles during times of rapid change: Motivator in chief

The post The Balancing Act: Taking A Systematic Approach To Hard Decisions In Times Of Rapid Change appeared first on LifeSciVC.




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Value Creation And Destruction: Dispersion of Performance In Biotech IPOs

The biotech IPO market in 2020 remains strong, despite the volatility and COVID headwinds. We’ve seen stellar pricings and good after-market performance, with ten new offerings already this year. And the queue for companies with active S1’s on file is

The post Value Creation And Destruction: Dispersion of Performance In Biotech IPOs appeared first on LifeSciVC.




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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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'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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Endurance, Energy and Cognitive Prowess Drive Sports Performance

The best sports nutrition formulas designed to improve performance draw from a pool of ingredients researched for benefits to energy production, cognitive function and endurance both in general and specifically concerning muscles.




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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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Women Advancing in APEC Region but More Reforms Needed

Policies impacting women’s economic advancement have improved in some areas, but more reforms are needed to enable women to fully thrive, reports the newly updated APEC Women and the Economy Dashboard 2019.




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APEC Finance Ministers Call for Economic Resilience and Financial Inclusion

Ministers address developments in the global economy and take action to safeguard the region’s growth.




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APEC Finance Ministers Issue Ministerial Statement

Finance Ministers from APEC member economies issued a joint statement reflecting the outcomes of the APEC Finance Ministers’ Meeting in Santiago, Chile, chaired by Chile’s Minister of Finance Felipe Larrain.




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APEC Advances Digitization of the APEC Business Travel Card

An APEC Business Travel Card mobile application will make travel easier and more secure




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EUA Transition To Clearance

From : Communities>>Regulatory Open Forum
Wondering if anyone has seen FDA guidance for timelines or procedures for all these Emergency Use Authorizations to transition to cleared IVD or Devices? Beverly Whitaker Indigo Consulting Group, LLC --------------------------------- Beverly Whitaker Beaufort SC 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 Dinar! ------------------------------ MARIA GUDIEL Brea CA United States ------------------------------