The Justice Department today announced that it has entered into a comprehensive settlement agreement that will transform the Commonwealth of Virginia’s system for serving people with developmental disabilities, including intellectual disabilities, and will resolve violations of the Americans with Disabilities Act.

"We expand opportunities in a wide range of areas, and today's agreement provides opportunity that will transform the Commonwealth of Virginia's system for delivering services to individuals with developmental disabilities, including intellectual disabilities, and improve the lives of thousands of Virginians with developmental disabilities," said Assistant Attorney General Perez.

A federal court has permanently barred David Champion from promoting a tax fraud scheme designed to assist his customers evade federal taxes, the Justice Department announced today.

U.S. Attorney General Eric Holder and Secretary of Homeland Security Janet Napolitano today visited Ottawa, Canada to participate in the Cross-Border Crime Forum with Canadian Minister of Justice and Attorney General Rob Nicholson, and Canadian Minister of Public Safety Vic Toews. Secretary Napolitano, Attorney General Holder and Minister Toews also signed a memorandum of understanding to better prevent and combat human smuggling and trafficking.

The Justice Department announced that the 2010 ADA Standards for Accessible Design go into effect today.

The Department of Justice today announced the filing of a lawsuit against the Nevada Division of Forestry (NDF) alleging that NDF discriminated against Ms. Tawnya Meyer, a former employee, when they fired her soon after she announced her pregnancy.

The Justice Department announced today an extension for existing swimming pools to comply with the 2010 Americans with Disabilities Act (ADA) Standards for Accessible Design. Existing pools must comply with the standards by Jan. 31, 2013.

F. Harvey Whittemore, 55, of Reno, Nevada, was charged with one count of making excessive campaign contributions, one count of making contributions in the name of others and two counts of making a false statement to a federal agency.

The United States and Canada today announced they are delivering on key commitments under the U.S.-Canada Beyond the Border Action Plan by releasing a joint Statement of Privacy Principles.

The settlement in this case represents the largest recovery the Civil Rights Division has obtained on behalf of a returning service member since 2004, when it assumed jurisdiction for the enforcement of the Uniformed Services Employment and Reemployment Rights Act.

The Department of Justice, the U.S. Environmental Protection Agency (EPA) and the Nevada Division of Environmental Protection announced a $25 million agreement for the cleanup of the Rio Tinto Mine, an abandoned copper mine in Elko County, Nev.

The Justice Department today announced an agreement with the city of North Adams, Mass., to improve access for people with disabilities to civic life in North Adams. The agreement was reached under Project Civic Access (PCA), the Justice Department’s initiative to ensure that cities, towns and counties throughout the country comply with the Americans with Disabilities Act (ADA). The compliance review was initiated in response to a complaint that the city’s police station was physically inaccessible.

The United States has sued a Las Vegas-based CPA and two others to stop an alleged tax-fraud scheme, the Justice Department announced today. Named as defendants in the civil injunction suit were CPA Wayne Reeves, Reeves’ wife, Diane Vaoga, and their alleged co-promoter, James Stoll. The government complaint was filed last month in Las Vegas with the U.S. District Court for the District of Nevada. Announcement of the court filing was delayed until Reeves was served with court papers this week.

A federal grand jury in Salt Lake City returned an indictment Wednesday afternoon charging Gerrit Timmerman III, 70, of Midvale, Utah, and Carol Sing, 73, of Henderson, Nevada, with one count of conspiracy to defraud the United States.

A federal grand jury in Nevada today returned an indictment against a former construction company owner for evading federal income and employment taxes.

The Justice Department announced today that it has entered into an interim settlement agreement with the State of Rhode Island and the City of Providence that will resolve violations of the Americans with Disabilities Act (ADA) for approximately 200 Rhode Islanders with intellectual and developmental disabilities (I/DD).

A former U.S. Army Reserve captain pleaded guilty today to accepting more than $90,000 in bribes from contractors while he was deployed to Iraq, announced Acting Assistant Attorney General Mythili Raman of the Justice Department’s Criminal Division and U.S. Attorney Daniel G. Bogden of the District of Nevada.

Assistant Attorney General for the Justice Department’s Tax Division Kathryn Keneally and U.S. Attorney Daniel G. Bogden for the District of Nevada today announced that Arthur Risser Jr., of Las Vegas, pleaded guilty to filing a false personal tax return for 2008.

The Department of Justice published a Notice of Proposed Rulemaking today intended to revise the department’s Americans with Disabilities Act Title II and Title III regulations to implement the requirements of the ADA Amendments Act of 2008.

The heads of the antitrust agencies of the United States, Canada and Mexico – Assistant Attorney General Bill Baer of the Department of Justice’s Antitrust Division, Chairwoman Edith Ramirez of the Federal Trade Commission, Canadian Commissioner of Competition John Pecman and President Alejandra Palacios Prieto of the Mexican Federal Competition Commission – met today in Washington, D.C., to discuss their mutual efforts to ensure continued effective antitrust enforcement cooperation in our increasingly interconnected markets.

The Department of Justice, the Federal Trade Commission (FTC), and the Competition Bureau Canada today issued a set of “best practices” to make more transparent how they coordinate merger reviews that affect the United States and Canada.

The United States has entered into a settlement agreement with the Kerr-McGee Corporation and certain of its affiliates (“New Kerr-McGee”), and their parent Anadarko Petroleum Corporation, in a fraudulent conveyance case brought by the United States and co-plaintiff Anadarko Litigation Trust (the “Trust”) in the bankruptcy of Tronox Inc. and its subsidiaries (Tronox), announced Deputy Attorney General James Cole, Acting Assistant Attorney General for the Justice Department’s Environment and Natural Resource Division Robert G. Dreher, U.S. Attorney for the Southern District of New York Preet Bharara, and U.S. Environmental Protection Agency Assistant Administrator Cynthia Giles.

Today, the Department of Justice and Office of the Director of National Intelligence released, in redacted form, a previously classified series of Foreign Intelligence Surveillance Court filings and orders from 2009-2010 concerning the collection of bulk telephony metadata under Section 215 of the USA Patriot Act. These documents relate to a robust interaction that occurred between the Department of Justice and a telecommunications service provider that included the provider’s review of prior FISC applications, orders and opinions, regarding lawful compliance with those orders.

Titanium Metals Corporation (TIMET), one of the world’s largest producers of titanium parts for jet engines, has agreed to pay a record $13.75 million civil penalty and perform an extensive investigation and cleanup of potential contamination stemming primarily from the unauthorized manufacture and disposal of PCBs (polychlorinated biphenyls) at its manufacturing facility in Henderson, Nevada.

A Las Vegas jury returned guilty verdicts yesterday against Alan Rodrigues, a former casino owner from Henderson, Nevada, Weston Coolidge, a former businessman from Las Vegas, and Joseph Prokop, a former National Football League punter from Upland, California, for conspiracy and fraud related to their promotion of a fraudulent tax product through the now-defunct National Audit Defense Network.

Assistant Attorney General Kathryn Keneally for the Tax Division and U.S. Attorney Daniel G. Bogden for the District of Nevada announced today that Damon Boswell of Las Vegas pleaded guilty to conspiracy to submit false federal income tax returns.

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.

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

A federal court has permanently barred Sea Nine Associates Inc. from promoting and selling an alleged nationwide tax scheme that involved using welfare benefit plans to unlawfully increase and accelerate tax deductions and avoid income taxes.

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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  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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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 …

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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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Shares of Relmada Therapeutics Inc. (RLMD) have gained 19 percent so far this year and trade around $37.

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

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

• Independent Data Monitoring Committee recommended continuing ongoing Phase 3 trial only in the more advanced “critical” group with Kevzara higher-dose versus placebo and discontinuing less advanced “severe” group

Celltrion has submitted an application to the European Medicines Agency (EMA) for its adalimumab biosimilar, currently known as CT-P17.

US-based drugmaker Mylan and partner, India-based biologicals specialist Biocon, announced on 28 April 2020 the launch of their pegfilgrastim biosimilar, Fulphila, in Canada. This is the second biosimilar from the pair to be launched in the country.

Posted by Reed Beall and Amir Attaran (respectively Phd Candidate and Professor, University of Ottawa) In 2005, the FDA launched an investigation into pharmaceuticals bought from “Canadian” internet pharmacies online and shipped to US consumers. Of 1700 packages these pharmacies supplied, fully 85 percent of those actually came from somewhere else, but 15 percent really came from Canada.  Worse, 32 of the drugs were found to be counterfeit.  All of these pacakges were ente [...]

Posted by Reed Beall and Amir Attaran (respectively Phd Candidate and Professor, University of Ottawa) On September 8, we posted a blogspot about our recent article published in Health Law in Canada, in which we write that Canada is providing haven for internet pharmacies located on Canadian soil that advertise and sell unapproved medicines illegally.  We called this a transnational transnational organized crime, which Canadian officials are knowingly facilitating.  We offered example [...]

Adam Silver told NBA players that a return to the court is up in the air but that games could be held in Las Vegas or Orlando, likely without fans.

The world's largest manufacturer says there's not enough capacity to quickly ramp up production to those levels.

Persons with disabilities would be provided six months’ pension in advance for adapting their homes as per their requirement.

Adamas Asset Management (AAM) has named Brock Silvers as its chief investment officer with immediate effect.

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