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Medication Access During Uncertain Times—Improving Provider Workflows to Help Patients in Need

Today’s guest post comes from Miranda Gill, Senior Director of Provider Network at CoverMyMeds.

Miranda reviews how the pandemic affects the ability of healthcare workers to complete administrative responsibilities like prior authorization. She then outlines how electronic automation is helping patients get needed medications while face-to-face interactions are restricted.

Learn more about healthcare IT solutions for providers and patients in CoverMyMeds’ 2020 Medication Access Report, or schedule a virtual meeting.
Read more »
        




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The hunt for a coronavirus vaccine – a perilous and uncertain path

The pressing need to find a solution to the pandemic means risks and shortcuts may have to be taken

The stakes could hardly be higher; the prize still tantalisingly out of reach. It is no exaggeration to say that the fate of many millions of people rests on the discovery of a vaccine for Covid-19 – the only sure escape route from the pandemic.

Yet the optimism that accompanied the launch of Oxford University’s human trials this week has to be put in context, and the hurdles facing the scientists need to be understood.

Continue reading...




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COVID-19 leading to shortage of orphan drugs in Russia

The ongoing spread of COVID-19 in Russia is leading to shortages of drugs against orphan diseases in…



  • Anti-virals/Coronavirus/Focus On/From our correspondent/Hydroxychloroquine/In Depth/Pharmaceutical/Public health/Rare diseases/Russia/Russian market

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An important option in the fight against antimicrobial resistance

Positive Phase III data for Recarbrio (imipenem/cilastatin/relebactam) have been announced by New Jersey,…



  • Antibiotics and Infectious diseases/Biotechnology/Drug Trial/Merck & Co/Recarbrio/Regulation/Research/US FDA/USA

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FDA backs Retevmo for certain lung and thyroid cancers

The US Food and Drug Administration has granted accelerated approval for Retevmo (selpercatinib) capsules…



  • Biotechnology/Eli Lilly/Focus On/Immuno-oncology/Loxo Oncology/Oncology/Regulation/Retevmo/selpercatinib/US FDA/USA

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Mexican Man Sentenced to 24 Years for Sex Trafficking of Minors and Transportation for the Purpose of Commercial Sex

Jorge Flores-Rojas, 44, an undocumented Mexican national, was sentenced to 24 years in prison by Chief Judge Robert J. Conrad, Jr. in Charlotte, N.C., for two counts of sex trafficking of minors and one count of interstate transportation of an adult for purposes of commercial sex. Flores-Rojas pled guilty to the charges on Oct. 7, 2008.



  • OPA Press Releases

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Justice Department Intervenes in Americans with Disabilities Act Lawsuit Against Transportation Provider

The Department announced that it has moved to intervene in a lawsuit filed in federal court in Jackson, Miss., challenging inaccessibility in Jackson’s public transportation system. The pending lawsuit, filed by 11 residents of Jackson with disabilities and two non-profit organizations that work on behalf of people with disabilities, alleges violations of the Americans with Disabilities Act and the Rehabilitation Act of 1973 (ADA).



  • OPA Press Releases

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Department of Justice Will Not Challenge Proposed Conduct of Less-Than-Truckload Freight Transportation Joint Venture

The Department will not challenge a proposal by seven regional less-than-truckload (LTL) freight transportation companies to bid jointly and engage in other collaborative activity as part of their nationwide LTL truck transportation services joint venture.



  • OPA Press Releases

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Indianapolis Man Sentenced for Transportation and Possession of Child Pornography

Michael Wildridge, 41, pleaded guilty today to transportation and possession of child pornography and was sentenced to 10 years in prison.



  • OPA Press Releases

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Justice Department Requires Ticketmaster Entertainment Inc. to Make Significant Changes to Its Merger with Live Nation Inc.

The Department will require Ticketmaster Entertainment Inc. to license its ticketing software, divest ticketing assets and subject itself to anti-retaliation provisions in order to proceed with its proposed merger with Live Nation Inc.



  • OPA Press Releases

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Justice Department Resolves Americans with Disabilities Act Lawsuit with Jackson, Mississippi, Public Transportation System

The United States has reached a comprehensive settlement agreement with the city of Jackson, Miss., to improve access to public transportation for individuals with disabilities.



  • OPA Press Releases

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Federal Court Bars St. Louis Tax Firm from Certain Conduct

A federal judge in St. Louis has barred two St. Louis tax preparers and their businesses from certain conduct the Justice Department announced today



  • OPA Press Releases

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Alaska Department of Transportation and Public Facilities to Pay Nearly $1 Million for Alleged Clean Water Act Violations

The Alaska Department of Transportation and Public Facilities has agreed to pay nearly $1 million to resolve allegations that it violated the Clean Water Act at numerous sites in Alaska



  • OPA Press Releases

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Massachusetts Bay Transportation Authority to Spend Millions to Reduce Commuter Train Emissions in Clean Air Act Settlement

In response to a federal enforcement action for excessive train engine idling, the Massachusetts Bay Transportation Authority (MBTA) and the Massachusetts Bay Commuter Railroad Company (MBCR) will spend more than $2 million to reduce diesel locomotive emissions throughout the MBTA’s commuter rail system.



  • OPA Press Releases

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Justice Department Announces Settlement of Litigation with AMC Entertainment Inc.

The Justice Department today announced a settlement agreement with AMC Entertainment Inc. to resolve a lawsuit filed under the Americans with Disabilities Act.



  • OPA Press Releases

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Justice Department Settles Case Against South Bend, Indiana, Public Transportation Corporation to Defend Employment Rights of Army Reservist

The Department of Justice announced today that it has resolved claims made by Stephen Ralston against the South Bend, Ind., Public Transportation Corporation (TRANSPO) under the Uniformed Services Employment and Reemployment Rights Act of 1994.



  • OPA Press Releases

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Statement of the Attorney General Regarding Investigation into the Interrogation of Certain Detainees

"On August 24, 2009, based on information the Department received pertaining to alleged CIA mistreatment of detainees, I announced that I had expanded Mr. Durham’s mandate to conduct a preliminary review into whether federal laws were violated in connection with the interrogation of specific detainees at overseas locations."



  • OPA Press Releases

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Michigan Man Pleads Guilty to Illegal Importation of Polar Bear Trophy from Canada

Rodger Dale DeVries, 73, a resident of Jenison, Mich., has pleaded guilty to illegally importing a polar bear trophy mount in 2007 from Canada into Michigan in violation of the Marine Mammal Protection Act.



  • OPA Press Releases

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Delaware Man Pleads Guilty to Production and Transportation of Child Pornography

Leonard Wasylyk, 49, pleaded guilty before U.S. District Judge Sue L. Robinson in the District of Delaware.



  • OPA Press Releases

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Deportation Order Upheld Against Detroit-Area Man Who Shot Jews as Nazi Policeman During World War II

The Board of Immigration Appeals has dismissed the appeal of John (Ivan) Kalymon of Troy, Mich., who was ordered removed from the United States earlier this year because of his participation in lethal acts of Nazi-sponsored persecution of Jews during World War II.



  • OPA Press Releases

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Tennessee Construction Company and Georgia Department of Transportation Agree to Pay $1.5 Million Penalty to Resolve Clean Water Act Violations

Wright Brothers Construction Co., of Charleston, Tenn., and the Georgia Department of Transportation (GDOT) have agreed to pay a $1.5 million penalty and spend more than $1.3 million to offset environmental damages to resolve alleged violations of the Clean Water Act.



  • OPA Press Releases

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Delaware Man Sentenced to 30 Years in Prison for Production and Transportation of Child Pornography

Leonard Wasylyk, 49, was also sentenced to lifetime supervised release and will be required to register as a sex offender in any jurisdiction in which he lives, works or attends school.



  • OPA Press Releases

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Three Tennessee Men Plead Guilty to Launching Mortar-Style Fireworks at African-Americans

James Smiley, 27, Colton Partin, 21, and Kyle Montgomery, 21, all of Chattanooga, Tenn., pleaded guilty today in U.S. District Court in Chattanooga for launching fireworks at African-Americans who were congregated outside their apartment building.



  • OPA Press Releases

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Memphis Man Sentenced for Interstate Transportation for Purpose of Prostitution in Connection with Sex Trafficking Scheme

Charles Kizer, 53, from Memphis, Tenn., was sentenced late Friday by U.S. District Judge Samuel H. Mays, Jr. to 10 years in prison for violating the Mann Act.



  • OPA Press Releases

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Statement of the Department of Justice’s Antitrust Division on Its Decision to Close Its Investigations of Google Inc.’s Acquisition of Motorola Mobility Holdings Inc. and the Acquisitions of Certain Patents by Apple Inc., Microsoft Corp. and Research in

The Antitrust Division closed its investigations into Google Inc.’s acquisition of Motorola Mobility Holdings Inc., the acquisitions by Apple Inc., Microsoft Corp. and Research in Motion Ltd. (RIM) of certain Nortel Networks Corporation patents, and the acquisition by Apple of certain Novell Inc. patents.



  • OPA Press Releases

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Three Tennessee Men Sentenced for Launching Mortar-Style Fireworks at African-Americans

Colton L. Partin, 22, of Apison, Tenn., Kyle C. Montgomery, 23, and James Smiley, 27, both of Chattanooga, Tenn., were sentenced today by Chief U.S. District Court Judge Curtis L. Collier. Smiley and Montgomery were sentenced to 12 months in prison and three years of supervised release for conspiring to intimidate African-Americans in the free exercise and enjoyment of housing rights secured to them by the laws of the United States. Partin was sentenced to 18 months probation, including six months home confinement. All three men will also serve 300 hours of community service. The men pleaded guilty on Jan. 6, 2012.



  • OPA Press Releases

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Florida Man Pleads Guilty to Transportation of Child Pornography

Anthony Mangione, 51, of Parkland, Fla., pleaded guilty today to one count of transportation of child pornography.



  • OPA Press Releases

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Statement of Attorney General Eric Holder on Closure of Investigation into the Interrogation of Certain Detainees

The Attorney General announced today the closure of the criminal investigations into the death of two individuals while in United States custody at overseas locations.



  • OPA Press Releases

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Statement on the Final Rule by the National Institute for Occupational Safety and Health to Include Certain Cancers into the World Trade Center Health Program

Sheila Birnbaum, Special Master of the September 11th Victim Compensation Fund (VCF), released the following statement on the final rule by the National Institute for Occupational Safety and Health (NIOSH) to include certain cancers into the World Trade Center Health Program.



  • OPA Press Releases

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US Customs and Border Protection Officer and Two Associates Charged with Undertaking Multi-Year Bribery and Alien Smuggling Operation Along the US/Mexico Border

A U.S. Customs and Border Protection (CBP) Officer, his girlfriend and an associate have been charged in Brownsville, Texas, for engaging in a multi-year bribery and alien smuggling operation along the U.S./Mexico.



  • OPA Press Releases

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Georgia Men Plead Guilty to Receiving Bribes in Transportation Scheme at Local Military Base

Two former employees at the Marine Corps Logistics Base Albany (MCLB-Albany) have pleaded guilty to receiving bribes related to a scheme to funnel freight hauling business to a local transportation company resulting in the loss of millions of dollars to the United States government.



  • OPA Press Releases

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Owners and Supervisor of Ambulance Transportation Company Plead Guilty in Los Angeles for Role in Ambulance Fraud Scheme

The owners and supervisor of Alpha Ambulance Inc. (Alpha), a now-defunct Los Angeles-area ambulance transportation company, have pleaded guilty in connection with an ambulance fraud scheme.



  • OPA Press Releases

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Canadian Citizen Arrested for Money Laundering in Connection with Illegal Importation and Trafficking of Narwhal Tusks

A Canadian man was arrested today in St. John, New Brunswick, Canada, on an extradition warrant requested by the United States for money laundering crimes related to the illegal importation and illegal trafficking of narwhal tusks.



  • OPA Press Releases

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Government Files Enforcement Action Against Four California Companies and Six Individuals to Stop the Importation of Dangerous Children’s Products

The government has asked a federal court in California to issue an injunction shutting down the importation and sales activities of four California companies and six individuals in connection with their imports of illegal children’s products containing, among other things, lead, phthalates and small parts inappropriate for children under age three.



  • OPA Press Releases

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Two Ocean Shipping Companies to Pay $3.4 Million to Settle Claims of Price Fixing Government Cargo Transportation Contracts

Sea Star Line LLC and Horizon Lines LLC have agreed to resolve allegations that they violated the False Claims Act by fixing the price of government cargo transportation contracts between the continental United States and Puerto Rico.



  • OPA Press Releases

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Justice Department Files Lawsuit Against the State of Hawaii and the Hawaii Department of Transportation for Sexual Harassment and Retaliation

The Justice Department announced today the filing of a lawsuit against the state of Hawaii and the state of Hawaii Department of Transportation Airports Division (HDOT-Airports) alleging that the defendants discriminated against former employee Sherry Valmoja by subjecting her to sexual harassment in violation of Title VII of the Civil Rights Act of 1964.



  • OPA Press Releases

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Justice Department Urges U.S. Sentencing Commission to Make Certain Individuals Incarcerated for Drug Offenses Retroactively Eligible for Reduced Sentences

Attorney General Eric Holder announced Tuesday that the Justice Department would formally support a proposal under consideration by the U.S. Sentencing Commission to allow certain individuals serving time in federal prison for nonviolent drug offenses to be eligible for reduced sentences.



  • OPA Press Releases

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Virginia-Based Move Management Company Pays More Than $500,000 to Settle Overbilling Claims in Connection with Transportation of Personal Property in Relocating Federal Employees

RE/MAX Allegiance Relocation Services, a Virginia-based move management company, has agreed to pay the government $509,807 to resolve allegations that it violated the False Claims Act by overbilling for transportation services, the Department of Justice announced today



  • OPA Press Releases

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PR—The Most Important Part of Trade Show Marketing

Natural product brands can boost trade show ROI by investing in PR to work with trade press via press releases and onsite interviews.




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RE: Traditional 510(k) RTA checklist

From : Communities>>Regulatory Open Forum
Yes, I think there were some previous posts where people uploaded Word versions you can get; just need to look around a little. ------------------------------ Richard Vincins RAC Vice President Global Regulatory Affairs ------------------------------




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RE: Traditional 510(k) RTA checklist

From : Communities>>Regulatory Open Forum
This message was posted by a user wishing to remain anonymous Why not use Adobe to fill out the form?  You will need it to compile the submission anyway.




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RE: Traditional 510(k) RTA checklist

From : Communities>>Regulatory Open Forum
This message was posted by a user wishing to remain anonymous When this was first issued we printed it out, filled in the answers with careful handwriting and then scanned it back in - which seemed to be perfectly acceptable. Since then we've converted their form to a fillable PDF.​




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Manufacturers report 'sporadic' resupply of sertraline following COVID-19 related shortage

Supplies of the selective serotonin reuptake inhibitor, sertraline, are returning to stock after manufacturers reported “industry-wide” supply challenges, exacerbated by export bans and border closures implemented as a result of COVID-19. 

To read the whole article click on the headline




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Manufacturer to move hydroxychloroquine production to the UK to avoid shortages

A manufacturer has announced plans to move production of hydroxychloroquine — currently being trialled as a COVID-19 treatment — to the UK from abroad to combat potential shortages.

To read the whole article click on the headline




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San Francisco will allow certain businesses to reopen beginning May 18

San Francisco will allow certain businesses to reopen beginning May 18 as it eases its stay-at-home orders. But officials warn that they will keep track to make coronavirus infections don't spike.




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Pharmacy Compounders Practicing Pursuant to Section 503A Can Get in the Mix: Compounding Shortage Drugs for Hospital Patients, with Some Limitations

By Karla L. Palmer



  • COVID19
  • Prescription Drugs and Biologics

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UPSC (IAS) Prelims 2020: Ministry-Wise Important Government Schemes (Ministry of Health & Family Welfare)

Check important government schemes launched by the Ministry of Health & Family Welfare which are important to study for the UPSC (IAS) Prelims 2020 exam.




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UPSC (IAS) Prelims 2020: Check Important Topics from Economics

Check the most important topics of Economics for the preparation of UPSC (IAS) Prelims Exam 2020. All the important topics have been added after a detailed analysis of the latest UPSC Prelims 2020 Syllabus.




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Immune dysfunction leads to mortality and organ injury in patients with COVID-19 in China: insights from ERS-COVID-19 study




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Communication between neonatologists and parents when prognosis is uncertain