k Two Companies to Pay $3.75 Million for Allegedly Causing Submission of Claims for Unreasonable or Unnecessary Rehabilitation Therapy at Skilled Nursing Facilities By www.justice.gov Published On :: Fri, 5 Sep 2014 14:14:52 EDT 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. Full Article OPA Press Releases
k Attorney General Holder Announces New Drug Take-Back Effort to Help Tackle Rising Threat of Prescription Drug Addiction and Opioid Abuse By www.justice.gov Published On :: Mon, 8 Sep 2014 10:33:26 EDT Calling prescription drug addiction an “urgent and growing threat” to our nation’s public health, Attorney General Eric Holder on Monday announced a new Drug Enforcement Administration(DEA) regulation that would allow pharmacies, hospitals, clinics, and other authorized collectors to serve as authorized drop-off sites for unused prescription drugs. Full Article OPA Press Releases
k United States Pursues Claims Against Neurosurgeon, Spinal Implant Company, Physician-Owned Distributorships and Their Non-Physician Owners for Alleged Kickbacks and Medically Unnecessary Surgeries By www.justice.gov Published On :: Mon, 8 Sep 2014 15:26:47 EDT The United States has filed two complaints under the False Claims Act against Michigan neurosurgeon Dr. Aria Sabit, spinal implant company Reliance Medical Systems, two Reliance distributorships—Apex Medical Technologies and Kronos Spinal Technologies—and the companies’ owners, Brett Berry, John Hoffman and Adam Pike. Full Article OPA Press Releases
k Justice Department Files Fair Housing Lawsuit Against Kent State University for Discrimination Against Students with Disabilities in University Housing By www.justice.gov Published On :: Mon, 8 Sep 2014 18:12:14 EDT 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. Full Article OPA Press Releases
k Justice Officials Meet with Key Stakeholders on Launch of Elder Justice Website By www.justice.gov Published On :: Mon, 8 Sep 2014 16:47:02 EDT Earlier today, Associate Attorney General Tony West, Assistant Attorney General Stuart Delery for the Civil Division and members of the Department’s Elder Justice Initiative met with stakeholders in the field of elder abuse and financial exploitation to launch the Elder Justice website. Full Article OPA Press Releases
k New York Property Owner and Manager Sentenced to 21 Months in Federal Prison for Conspiring to Violate the Clean Air Act By www.justice.gov Published On :: Mon, 8 Sep 2014 17:25:54 EDT John Francis Mills, the owner of more than a dozen properties in Malone, New York, and Terrance Allen, the maintenance manager of Mills’ properties, were sentenced today by U.S. District Judge Thomas J. McAvoy to serve 21 months each in prison for conspiring to violate the Clean Air Act standards for the safe removal of asbestos. Full Article OPA Press Releases
k Former TierOne Bank Executive Pleads Guilty for His Role in Scheme to Defraud Bank’s Shareholders and Regulators By www.justice.gov Published On :: Tue, 9 Sep 2014 16:59:45 EDT 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. Full Article OPA Press Releases
k Remarks by Assistant Attorney General Karol Mason Before the Senate Committee on Homeland Security and Governmental Affairs By www.justice.gov Published On :: Tue, 9 Sep 2014 11:53:06 EDT Chairman Carper, Ranking Member Coburn and distinguished members of the committee, thank you for inviting me to speak with you today about the Department of Justice’s role in supporting state, local and tribal law enforcement agencies. Full Article Speech
k Remarks by Attorney General Eric Holder at the Executive Office of U.S. Attorneys Director’s Awards Ceremony By www.justice.gov Published On :: Wed, 10 Sep 2014 10:34:45 EDT Thank you, Monty [Wilkinson], not only for your kind words – but also for your outstanding leadership of the Executive Office for United States Attorneys. Full Article Speech
k Attorney General Holder Delivers Remarks at Farewell Ceremony for Associate Attorney General West By www.justice.gov Published On :: Wed, 10 Sep 2014 15:15:58 EDT "At every level, Tony West has come to exemplify what it means to be a public servant in the truest sense. To many who are at risk and in need, he has become known as a champion. To those who have broken the law and victimized others, he has been a fierce and determined guardian of the public trust. And to me, he has been a trusted advisor, a dedicated colleague, and a dear friend." Full Article Speech
k Associate Attorney General West Delivers Farewell Remarks By www.justice.gov Published On :: Wed, 10 Sep 2014 15:18:00 EDT "I love this department because of its unique mission. It's an audacious one -- I suppose with a name like “Justice” audacity is appropriate. It's a mission that speaks to the fundamental importance of the Rule of Law, as represented by that statue on your far right, aptly named the “Majesty of Law,” a bundle of arrows in hand." Full Article Speech
k Black P-Stones Gang Member Sentenced to Over 20 Years in Prison for Racketeering Conspiracy and Firearm Charges By www.justice.gov Published On :: Thu, 11 Sep 2014 12:37:38 EDT A 26-year-old man from Newport News, Virginia, was sentenced today to serve 255 months in prison, followed by five years of supervised release, for engaging in numerous gang-related crimes as a member of the Black P-Stones, including the shooting of a rival gang member, marijuana dealing and lying to a federal grand jury. Full Article OPA Press Releases
k East Side Bloods Gang Member Sentenced to 30 Years in Prison for Racketeering Conspiracy, Attempted Murder and Firearms Charges By www.justice.gov Published On :: Thu, 11 Sep 2014 13:11:15 EDT An East Side Bloods (ESB) gang member from Scottsdale, Arizona, was sentenced late yesterday to serve 30 years in prison for his role in the violent street gang, which operated on the Salt River Pima-Maricopa Indian Community reservation. Full Article OPA Press Releases
k Hewlett-Packard Russia Pleads Guilty to and Sentenced for Bribery of Russian Government Officials By www.justice.gov Published On :: Thu, 11 Sep 2014 17:41:04 EDT 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. Full Article OPA Press Releases
k Two Men, Including Former Car Salesman at Prominent Los Angeles Dealership, Charged with Conspiring to Roll Back Odometers in Large-Scale Scheme That Defrauded Car Buyers By www.justice.gov Published On :: Fri, 12 Sep 2014 10:08:21 EDT A former salesman at a prominent Los Angeles car dealership and another Southern California man were charged with odometer tampering, the Justice Department announced today. Full Article OPA Press Releases
k United States Seeks Civil Contempt Against Bayer Corporation for Failure to Substantiate Promotional Claims for Phillips’ Colon Health By www.justice.gov Published On :: Fri, 12 Sep 2014 10:49:19 EDT 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. Full Article OPA Press Releases
k Remarks by Attorney General Eric Holder at the Hispanic National Bar Association 39th Annual Convention By www.justice.gov Published On :: Fri, 12 Sep 2014 12:45:05 EDT Buenas tardes. Muchas gracias por sus emotivas palabras y su calurosa bienvenida. It’s a privilege to help welcome the Hispanic National Bar Association to our nation’s capital for your 39th Annual Convention. And it’s a great pleasure, as always, to be in such distinguished company. Full Article Speech
k Attorney General Holder Records Message for Cartoon Network’s “I Speak up” Campaign to Combat Bullying By www.justice.gov Published On :: Mon, 15 Sep 2014 11:47:41 EDT The Justice Department announced Monday that Attorney General Eric Holder has recorded a video message as part of the Cartoon Network’s “I Speak Up” campaign to combat bullying. The project urges young people to speak up in order to help bring bullying situations to an end. Full Article OPA Press Releases
k Owner of Costa Rican Call Center Pleads Guilty to Defrauding Elderly Through Sweepstakes Scam By www.justice.gov Published On :: Mon, 15 Sep 2014 13:00:25 EDT 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. Full Article OPA Press Releases
k 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 By www.justice.gov Published On :: Mon, 15 Sep 2014 13:33:06 EDT 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. Full Article OPA Press Releases
k Associate Attorney General West Delivers Remarks at the Legal Services Corporation 40th Anniversary Kick-off Conference By www.justice.gov Published On :: Mon, 15 Sep 2014 15:25:55 EDT Thank you, John, not only for that kind introduction but also for your exemplary leadership as chair of the LSC Board. LSC really exemplifies that spirit Attorney General Robert Kennedy used to talk about – that as lawyers, we have an obligation to enlist our skills and ourselves in engagements that reach beyond the horizons of our parochial legal practices. And over the last five-and-a-half years I’ve served in this Administration, I’ve been fortunate to get to know John and LSC President Jim Sandman, and I know the movement for expanding access to justice in this country is better and stronger because they’re helping to lead this effort, so my thanks to them. Full Article Speech
k Rochester Man Indicted on Charges of Attempting to Provide Material Support to ISIS, Attempting to Kill U.S. Soldiers and Possession of Firearms and Silencers By www.justice.gov Published On :: Tue, 16 Sep 2014 19:14:07 EDT Attorney General Eric Holder, Assistant Attorney General for National Security John Carlin and U.S. Attorney William J. Hochul Jr. for the Western District of New York announced today that a federal grand jury in Rochester has returned a seven-count indictment charging Mufid A. Elfgeeh, 30, of Rochester, with three counts of attempting to provide material support and resources to the Islamic State of Iraq and the Levant (ISIL), aka the Islamic State of Iraq and Syria (ISIS), a designated foreign terrorist organization. In addition, Elfgeeh is also charged with one count of attempted murder of current and former members of the United States military, one count of possessing firearms equipped with silencers in furtherance of a crime of violence, and two counts of receipt and possession of unregistered firearm silencers. Full Article OPA Press Releases
k Remarks by Attorney General Eric Holder at the Legal Services Corporation 40th Anniversary Event By www.justice.gov Published On :: Tue, 16 Sep 2014 20:08:47 EDT Thank you, Dean [Martha] Minow, for those kind words – and thank you all for being here. I also want to recognize, and thank, my good friends John Levi and Jim Sandman for their leadership of the Legal Services Corporation over the years – and for the lifetimes of tireless work that they have dedicated to vulnerable populations from coast to coast. Finally, I want to thank each and every one of you – the dedicated men and women who are making LSC’s work possible; who are helping to shine a light on the current challenges facing the legal aid community; and who are leading us to redouble our efforts to forge the more just society that all Americans deserve. It’s gratifying to see so many diverse people and interests – from academia and government service, to private practice and corporate enterprise – converging to support equal justice under law. Full Article Speech
k Remarks by Assistant Attorney General for the Criminal Division Leslie R. Caldwell at the Taxpayers Against Fraud Education Fund Conference By www.justice.gov Published On :: Wed, 17 Sep 2014 10:26:29 EDT 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. Full Article Speech
k Remarks by Principal Deputy Assistant Attorney General for the Criminal Division Marshall L. Miller at the Global Investigation Review Program By www.justice.gov Published On :: Wed, 17 Sep 2014 12:54:10 EDT A true cooperator – whether a mobster or a company – must forthrightly provide all the available facts and evidence so that the most culpable individuals can be prosecuted. If a corporation wants credit for cooperation, it must engage in comprehensive and timely cooperation; lip service simply will not do. Corporations do not act criminally, but for the actions of individuals. The Criminal Division intends to prosecute those individuals, whether they’re sitting on a sales desk or in a corporate suite. Full Article Speech
k Attorney General Holder Remarks on Financial Fraud Prosecutions at NYU School of Law By www.justice.gov Published On :: Wed, 17 Sep 2014 14:28:51 EDT 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 Full Article Speech
k Two Former Rabobank Traders Indicted for Alleged Manipulation of U.S. Dollar, Yen Libor Interest Rates By www.justice.gov Published On :: Thu, 23 Oct 2014 11:08:25 EDT Two former Coöperatieve Centrale Raiffeisen-Boerenleenbank B Full Article OPA Press Releases
k Deutsche Bank's London Subsidiary Agrees to Plead Guilty in Connection with Long-Running Manipulation of LIBOR By www.justice.gov Published On :: Fri, 24 Apr 2015 09:35:43 EDT 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 Full Article OPA Press Releases
k Father Of Former Investment Bank Managing Director Pleads Guilty To Insider Trading Conspiracy By www.justice.gov Published On :: Wed, 12 Aug 2015 21:09:53 EDT 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 Full Article OPA Press Releases
k 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 By www.justice.gov Published On :: Fri, 18 Dec 2015 11:45:41 EST 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 Full Article Speech
k Deputy Attorney General Sally Quillian Yates Delivers Remarks at American Banking Association and American Bar Association Money Laundering Enforcement Conference By www.justice.gov Published On :: Fri, 18 Dec 2015 11:45:40 EST Remarks as prepared for delivery Thank you, Buddy [Wilmer Parker], for that kind introduction Full Article Speech
k Morgan Stanley Agrees to Pay $2.6 Billion Penalty in Connection with Its Sale of Residential Mortgage Backed Securities By www.justice.gov Published On :: Wed, 17 Feb 2016 19:56:23 EST The Justice Department today announced that Morgan Stanley will pay a $2 Full Article OPA Press Releases
k Former Postal Clerk Pleads Guilty to Stealing Mail By www.justice.gov Published On :: Wed, 23 Mar 2016 20:45:27 EDT NORFOLK, Va Full Article OPA Press Releases
k New York Man Pleads Guilty to Conspiracy to Defraud U.S. Defense Contractors By www.justice.gov Published On :: Tue, 29 Mar 2016 20:45:42 EDT ALEXANDRIA, Va Full Article OPA Press Releases
k Norfolk Man Sentenced to Prison for Mail and Wire Fraud By www.justice.gov Published On :: Thu, 28 Apr 2016 20:45:25 EDT NEWPORT NEWS, Va Full Article OPA Press Releases
k Former Postal Worker Sentenced to Prison for Workers’ Comp Fraud By www.justice.gov Published On :: Thu, 5 May 2016 08:45:25 EDT NORFOLK, Va Full Article OPA Press Releases
k Navy Senior Chief Indicted in ID Theft and Bank Fraud Scheme By www.justice.gov Published On :: Thu, 5 May 2016 20:45:25 EDT NORFOLK, Va Full Article OPA Press Releases
k Two Former Deutsche Bank Employees Indicted on Fraud Charges in Connection with Long-Running Manipulation of Libor By www.justice.gov Published On :: Thu, 2 Jun 2016 14:45:33 EDT 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 Full Article OPA Press Releases
k Former Nurse Pleads Guilty to ID Theft and Bank Fraud By www.justice.gov Published On :: Fri, 24 Jun 2016 20:45:27 EDT RICHMOND, Va Full Article OPA Press Releases
k New FDA guidance on alternate approaches in premarket notification for Class II medical devices By feedproxy.google.com Published On :: Fri, 20 Dec 2019 14:09:57 +0000 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 … Continue reading » Full Article Cato Research FDA FDA Regulatory Guidances Medical Device FDA Guidances medical devices
k Curious to know if Bitcoin is here to stay ? By www.rttnews.com Published On :: Sat, 09 May 2020 15:15:05 GMT Read the latest developments from the cryptocurrency space, breaking news and analysis on Bitcoin and blockchain on RTTNews. Know more about altcoins, mining, ICOs, warnings and regulation. Find out how to acquire and trade digital currencies. Full Article
k Axsome Therapeutics (AXSM) Advances To Cross $100-Mark By www.rttnews.com Published On :: Mon, 27 Apr 2020 10:45:29 GMT Axsome Therapeutics Inc.'s (AXSM) phase II/III trial of investigational drug AXS-05 in Alzheimer's disease agitation has met the primary endpoint. Full Article
k FDA Warns Of Risks Related To Use Of Anti-malaria Drugs For COVID-19 By www.rttnews.com Published On :: Mon, 27 Apr 2020 13:03:03 GMT Though it issued an Emergency Use Authorization (EUA) for anti-malaria drugs to treat or prevent coronavirus (COVID-19), the U.S. Food and Drug Administration (FDA) reiterated its warning about the known side effects of hydroxychloroquine and chloroquine, including serious and potentially life-threatening heart rhythm problems. Full Article
k Will Krystal (KRYS) Continue To Shine? By www.rttnews.com Published On :: Thu, 07 May 2020 09:23:26 GMT Shares of Krystal Biotech Inc. (KRYS) have now more than doubled in value since touching a 52-week low of $22.02 on June 14, 2019. Full Article
k IMMU Gets Early FDA Nod, KNSA's PN Trial Meets Goals, MYOV In Good Spirits By www.rttnews.com Published On :: Thu, 23 Apr 2020 06:16:08 GMT Today's Daily Dose brings you news about FDA approval of Immunomedics' breast cancer drug; promising results from Kiniksa Pharma's prurigo nodularis trial; Mallinckrodt's regulatory catalyst; Myovant Sciences' phase III SPIRIT 2 study results and another disappointment in Parkinson's disease drug development space. Full Article
k Ocean Spray Recalls Pink Lite Cranberry Juice For Undeclared Sulfites By www.rttnews.com Published On :: Thu, 23 Apr 2020 11:43:59 GMT 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 Full Article
k Medifast Recalls Optavia Oatmeal For Undeclared Milk By www.rttnews.com Published On :: Tue, 05 May 2020 11:38:17 GMT 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. Full Article
k LabCorp's COVID-19 At-Home Test Kit Receives EUA From FDA - Quick Facts By www.rttnews.com Published On :: Tue, 21 Apr 2020 11:06:05 GMT Life sciences company LabCorp (LH) announced Tuesday that it has received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its COVID-19 at-home test kit. Full Article
k Biotech Stocks Facing FDA Decision In May 2020 By www.rttnews.com Published On :: Tue, 28 Apr 2020 02:29:38 GMT So far this year, 16 novel drugs have received FDA approval compared to 9 which were greenlighted during the same period last year. Now, let's take a look at the biotech stocks that are awaiting a regulatory decision in May 2020. Full Article
k ARDS In COVID-19 Battle, AKBA's Kidney Disease Drug Hits Goals, VAPO On A Roll By www.rttnews.com Published On :: Wed, 06 May 2020 05:15:35 GMT Today's Daily Dose brings you news about the acquisition of Portola by Alexion; encouraging results from TG Therapeutics' chronic lymphocytic leukemia trial; Akebia's INNO2VATE trial results; and Vapotherm's Q1 financial results. Full Article