al 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
al U.S. Settlement with Michigan Utility to Reduce Emissions at Its Coal-Fired Power Plants, Fund Projects to Benefit Environment and Communities By www.justice.gov Published On :: Tue, 16 Sep 2014 13:03:59 EDT 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. Full Article OPA Press Releases
al Department of Justice and Federal Trade Commission Sign Cooperation Agreement with Colombian Antitrust Agency By www.justice.gov Published On :: Tue, 16 Sep 2014 11:33:49 EDT Assistant Attorney General Bill Baer of the Department of Justice’s Antitrust Division has signed an antitrust cooperation agreement with the Colombian antitrust agency on behalf of the Department of Justice. The agreement also was signed by Federal Trade Commission Chairwoman Edith Ramirez, and went into effect today with the signature of Pablo Felipe Robledo, Colombia’s Superintendent of Industry and Commerce. Full Article OPA Press Releases
al Detroit-Area Doctor Admits to Providing Medically Unnecessary Chemotherapy to Patients By www.justice.gov Published On :: Tue, 16 Sep 2014 16:36:59 EDT 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. Full Article OPA Press Releases
al 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
al Attorney General Holder Announces Partnership with Department of Housing and Urban Development to Improve Civil Legal Aid for Juveniles By www.justice.gov Published On :: Tue, 16 Sep 2014 20:05:14 EDT 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. Full Article OPA Press Releases
al 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
al Pennsylvania Man Pleads Guilty in Conspiracy to Illegally Export Restricted Laboratory Equipment to Syria By www.justice.gov Published On :: Wed, 17 Sep 2014 11:22:35 EDT 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 Full Article OPA Press Releases
al Florida Home Health Care Company and Its Owners Agree to Resolve False Claims Act Allegations for $1.65 Million By www.justice.gov Published On :: Wed, 17 Sep 2014 11:31:48 EDT 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. Full Article OPA Press Releases
al Hawaii Man Sentenced to 87 Months Imprisonment for Communicating Classified National Defense Information to Unauthorized Person By www.justice.gov Published On :: Wed, 17 Sep 2014 17:50:08 EDT 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. Full Article OPA Press Releases
al 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
al 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
al 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
al Justice Department Announces National Effort to Build Trust Between Law Enforcement and the Communities They Serve By www.justice.gov Published On :: Thu, 18 Sep 2014 11:01:37 EDT Attorney General Eric Holder announced today the launch of the Justice Department’s National Initiative for Building Community Trust and Justice. Full Article OPA Press Releases
al 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
al Five Northern California Real Estate Investors Indicted for Bid Rigging and Fraud at Public Foreclosure Auctions By www.justice.gov Published On :: Thu, 23 Oct 2014 11:08:23 EDT A federal grand jury in San Francisco returned an eight-count indictment against five real estate investors for their role in bid rigging and fraud schemes at foreclosure auctions in Northern California, the Department of Justice announced Full Article OPA Press Releases
al Alabama Real Estate Investor Pleads Guilty to Conspiracy to Commit Mail Fraud By www.justice.gov Published On :: Mon, 3 Nov 2014 14:58:31 EST 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 Full Article OPA Press Releases
al Eleven Northern California Real Estate Investors Indicted for Bid Rigging and Fraud at Public Foreclosure Auctions By www.justice.gov Published On :: Wed, 3 Dec 2014 09:45:53 EST A federal grand jury in San Francisco returned three multi-count indictments against eleven real estate investors for their role in bid rigging and fraud schemes at foreclosure auctions in Northern California, the Department of Justice announced Full Article OPA Press Releases
al Northern California Real Estate Investor Agrees to Plead Guilty to Bid Rigging and Fraud at Public Foreclosure Auctions By www.justice.gov Published On :: Wed, 3 Dec 2014 09:45:52 EST 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 Full Article OPA Press Releases
al Justice Department and State Partners Secure $1.375 Billion Settlement with S&P for Defrauding Investors in the Lead Up to the Financial Crisis By www.justice.gov Published On :: Tue, 3 Feb 2015 16:01:53 EST 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. Full Article OPA Press Releases
al Northern California Real Estate Investor Agrees to Plead Guilty to Bid Rigging and Fraud Conspiracies at Public Foreclosure Auctions By www.justice.gov Published On :: Thu, 9 Apr 2015 12:52:09 EDT 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 Full Article OPA Press Releases
al Former Owner of Empire Towers Pleads Guilty for Fraudulent $7 Million Bond Scheme and Filing False Tax Return By www.justice.gov Published On :: Thu, 28 May 2015 13:20:24 EDT 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 Full Article OPA Press Releases
al Defendant In Prior SEC Enforcement Action Arrested And Charged In Manhattan Federal Court For Scheme To Hide Assets From Court-Appointed Receiver And The Court By www.justice.gov Published On :: Wed, 26 Aug 2015 20:45:21 EDT Preet Bharara, the United States Attorney for the Southern District of New York, Diego Rodriguez, the Assistant Director-in-Charge of the New York Field Office of the Federal Bureau of Investigation (“FBI”), and Philip R Full Article OPA Press Releases
al 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
al Real Estate Investor Pleads Guilty to Bid Rigging and Fraud Conspiracies at Georgia Public Foreclosure Auctions By www.justice.gov Published On :: Wed, 7 Oct 2015 20:45:21 EDT 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 Full Article OPA Press Releases
al 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
al Former California Attorney Pleads Guilty in International Investment Fraud Scheme By www.justice.gov Published On :: Wed, 25 Nov 2015 08:45:26 EST 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 Full Article OPA Press Releases
al Executives of Swiss and Las Vegas Companies Convicted in International Investment Fraud Scheme By www.justice.gov Published On :: Thu, 10 Dec 2015 08:45:28 EST A federal jury in Las Vegas convicted two men of conspiracy, wire fraud and securities fraud yesterday for their roles in an approximately $10 million international investment fraud scheme involving numerous victims Full Article OPA Press Releases
al Justice Department Reaches $470 Million Joint State-Federal Settlement with HSBC to Address Mortgage Loan Origination, Servicing and Foreclosure Abuses By www.justice.gov Published On :: Wed, 17 Feb 2016 19:56:24 EST The Justice Department, the Department of Housing and Urban Development (HUD) and the Consumer Financial Protection Bureau, along with 49 state attorneys general and the District of Columbia’s attorney general, have reached a $470 million agreement with HSBC Bank USA NA and its affiliates (collectively, HSBC) to address mortgage origination, servicing and foreclosure abuses Full Article OPA Press Releases
al 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
al Former California Attorney Sentenced to 60 Months for His Role in International Investment Fraud Scheme By www.justice.gov Published On :: Tue, 23 Feb 2016 20:45:29 EST A Las Vegas man was sentenced today to 60 months in prison for his role in an investment fraud scheme that promoted fraudulent investment opportunities and caused more than $5 million in losses to investors Full Article OPA Press Releases
al 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
al Alexandria Adult Day Healthcare Center Settles Civil Fraud Allegations By www.justice.gov Published On :: Wed, 4 May 2016 08:45:24 EDT ALEXANDRIA, Va Full Article OPA Press Releases
al 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
al Former Director of General Services Administration Division and Husband Indicted for Fraud and Nepotism By www.justice.gov Published On :: Wed, 15 Jun 2016 14:45:25 EDT ALEXANDRIA, Va Full Article OPA Press Releases
al Toano Man Pleads Guilty to Impersonating a Federal Agent By www.justice.gov Published On :: Fri, 24 Jun 2016 20:45:27 EDT NEWPORT NEWS, Va Full Article OPA Press Releases
al 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
al What’s New Health Canada? November 2019 Updates By feedproxy.google.com Published On :: Fri, 20 Dec 2019 14:41:48 +0000 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 … Continue reading » Full Article Canadian Regulatory Affairs Cato Research Health Canada regulatory
al What’s New Health Canada? January and February 2020 Updates By feedproxy.google.com Published On :: Wed, 04 Mar 2020 17:52:44 +0000 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 … Continue reading » Full Article Health Canada Updates Health Canada Regulatory Authorities
al Consideration for ongoing clinical trials: Ensuring Participant Safety and Adapting New Processes during COVID‑19 Pandemic By feedproxy.google.com Published On :: Wed, 29 Apr 2020 13:00:12 +0000 By Ashley Henderson, PhD, CATO SMS Scientist 1.0 INTRODUCTION The COVID‑19 pandemic has added an unprecedented set of challenges to the conduct of clinical trials including quarantines, travel limitations, site closures, and interruptions in the supply chain of investigational products. In acknowledgement of these challenges, the Food and Drug Administration (FDA) recognizes that protocol modifications … Continue reading » Full Article Clinical Trials CATOSMS COVID-19
al What’s New Health Canada? By feedproxy.google.com Published On :: Thu, 07 May 2020 21:44:25 +0000 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 … Continue reading » Full Article Canadian Regulatory Affairs Cato Research Health Canada CATOSMS
al Shot Roster: COVID-19 Vaccines In Human Trials By www.rttnews.com Published On :: Fri, 01 May 2020 00:58:48 GMT The ongoing COVID-19 pandemic has sickened over 3.25 million people and has killed 233,014 people, according to data from Johns Hopkins University. Full Article
al SAVA Gets Funding For AD Drug, JNJ Hits All-time High, ENZ On Watch By www.rttnews.com Published On :: Fri, 24 Apr 2020 05:43:19 GMT 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. Full Article
al Vir Biotechnology, Alnylam Identify VIR-2703 Candidate For Treatment Of COVID-19 By www.rttnews.com Published On :: Mon, 04 May 2020 11:51:31 GMT Vir Biotechnology, Inc. (VIR) and Alnylam Pharmaceuticals, Inc. (ALNY) announced Monday that they have selected a development candidate (DC) for VIR-2703 (ALN-COV), an investigational RNAi therapeutic targeting the SARS-CoV-2 (COVID-19) genome. Full Article
al Lupin Pharma: Phase 3 Trial Of Single-Dose Solosec Met Primary Endpoint By www.rttnews.com Published On :: Mon, 04 May 2020 11:56:29 GMT Lupin Pharmaceuticals Inc. (LUPIN, 500257) on Monday announced positive top-line results from its pivotal Phase 3 clinical trial to assess the efficacy and safety of single-dose Solosec or secnidazole 2g oral granules in 147 female patients with trichomoniasis. Full Article
al Avadel (AVDL) Soars On REST-ON Trial Results By www.rttnews.com Published On :: Mon, 27 Apr 2020 12:11:18 GMT 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. Full Article
al 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
al Gilead's Remdesivir Becomes 1st Drug Allowed For Emergency Use For COVID-19 By www.rttnews.com Published On :: Sat, 02 May 2020 02:41:07 GMT The FDA has issued emergency use authorization for Gilead Science Inc's (GILD) antiviral drug Remdesivir for the treatment of COVID-19 in adults and children hospitalized with severe disease. Full Article
al 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
al 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