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Window on Washington - This Week in the Nation's Capital - Vol. 1, Issue 9

by Clark Hill PLC on

Agriculture - Lawmakers to Introduce Organic Research Funding Bill: A bipartisan trio of House lawmakers were set to introduce legislation late May 16 that would boost Department of Agriculture funding for research into...more

Washington, D.C. Update – May 2017

by Baker Donelson on

April saw the debate in Congress heat up as Justice Neil Gorsuch was confirmed for a seat on the Supreme Court, House Republicans suspended, restarted and then ultimately succeeded in their effort to repeal and replace the...more

Global Inquiries into Drug Price Increases

European competition authorities announced this week an investigation into Aspen Pharmacare’s recent price hikes of five cancer drugs. The European Commission said in a press release that it had “information indicating that...more

Dr. Reddy’s to Install GE Healthcare’s FlexFactory

by Goodwin on

GE Healthcare announced today that Dr. Reddy’s will install GE Healthcare’s FlexFactory in Dr. Reddy’s facility in Hyderabad, India. According to the press release, “FlexFactory will help Dr. Reddy’s increase its capacity to...more

WannaCry Global Ransomware Attack

A global ransomware attack began early last Friday and has affected businesses and government entities in 150 countries, including Britain’s national health system, FedEx, Spain’s Telefónica, and the Russian Interior...more

Take-Aways from WannaCry

We have read multiple reports on WannaCry and if you are reading this and don’t know what WannaCry is, Google it for the background story. The clear message is this is not the last major attack we will see, and future attacks...more

Privacy Tip #88 – The Challenge of Keeping Up with Patches

Over the past week, many clients and individuals have asked me why some companies and health care facilities were devastated by the WannaCry ransomware, and why others made it through the weekend without a blink of an eye....more

The Pricing of Patented Drugs in Canada: Stakeholder Consultation Period Open Until June 28, 2017

by Smart & Biggar on

The Patented Medicine Prices Review Board (PMPRB) regulates the price of patented medicines in Canada by determining whether a price is excessive. The Board is revisiting its approach to pricing, and has now released a...more

WannaCry Malware and Medical Device Security

The WannaCry virus has infected and frozen computers in many industries around the world. According to a news source report, the virus has extorted doctors and hospital administrators for the keys to unlock and regain access...more

WannaCry Ransomware Attack: What Happened and How to Address

by Seyfarth Shaw LLP on

Recently, a widespread global ransomware attack has struck hospitals, communication, and other types of companies and government offices around the world, seizing control of affected computers until the victims pay a ransom. ...more

Ransomware Attack – Quick Facts

By now, you may have heard about the global ransomware attacks affecting health care and other organizations throughout the world, in particular the United Kingdom, but also in the United States. The ransomware variant,...more

Managing Sanctions and Export Control Risks in the Health Care Industry

by Ropes & Gray LLP on

Over the past 15 years, pharmaceutical manufacturers, medical device companies, and other participants in the health care industry have been regular targets of U.S. Foreign Corrupt Practices Act (“FCPA”) enforcement actions...more

WannaCry Ransomware Update

On Saturday May 13, 2017 the Federal Bureau of Investigations (FBI), Cyber Division, in conjunction with the Department of Homeland Security issued an FBI FLASH report pertaining to indicators associated with the latest...more

Update on Recommendations and Initiatives of EU Regulators Ahead of Brexit

by Jones Day on

On April 27, 2017, the European Medicines Agency ("EMA") held a meeting with the heads of the National Competent Authorities ("NCAs") of the European Union ("EU")/European Economic Area ("EEA") Member States to discuss the...more

EMA Adopts a Guidance Concerning Periodic Safety Update Reports

by Jones Day on

On April 6, 2017, the European Medicines Agency ("EMA") issued new guidance and recommendations concerning periodic safety update reports ("PSURs") of nationally authorized medicinal products. These recommendations form part...more

UK's Regulator Announces Its Top Priorities in the Lead Up to Brexit

by Jones Day on

The Medicines and Healthcare products Regulatory Agency (MHRA), the UK's pharmaceutical and medical devices regulator, has recently released its 2017-2018 business plan. Of the 10 key priorities identified by the MHRA, life...more

What's New in Washington: 10 Things You Need to Know

Congress returned to session the week of April 24 following a two-week recess. Active discussions and debate surrounding the American Health Care Act (AHCA) and efforts to “repeal-and-replace” the Affordable Care Act resumed...more

Medical Device Regulation Update

by K&L Gates LLP on

On 5 May 2017, the Medical Device Regulation ("MDR") was published in the Official Journal of the European Union and comes into effect on 26 May 2017. The Commission proposed back in 2012 to revise the existing regulatory...more

The New EU Regulation on Medical Devices Aims at Enhanced Product Safety and Further Harmonization

by McDermott Will & Emery on

On May 5, 2017, the new Regulation on Medical Devices (MDR) and the new Regulation on In Vitro Diagnostics (IVDR) have been published in the European Official Journal. The Regulations will become effective 20 days after...more

Window on Washington - This Week in the Nation's Capital - May 5, 2017 Vol. 1, Issue 7

by Clark Hill PLC on

Spending Bill: The U.S. Senate cleared legislation to fund the government for the rest of the fiscal year, sending it to President Trump for his signature. The vote was 79-18 on H.R. 244, which provides $1.1t in base...more

World Health Organization announces biosimilar prequalification project

by Goodwin on

The World Health Organization (WHO) announced today plans to launch a pilot project for prequalifying biosimilar medicines later this year. The project will initially focus on biosimilar versions of two cancer treatments,...more

To DPO or Not to DPO: Revised Guidance Issued on Data Protection Officers Under GDPR

by Ballard Spahr LLP on

If you are a hospital processing European Union (EU) patient data, if you maintain EU customer loyalty programs, or if you engage in behavioral advertising of EU citizens, you may be required to appoint a data protection...more

Sandoz’s Biosimilars Rituximab and Etanercept are Recommended for Approval in Europe

by Goodwin on

On Friday, April 21, 2017, Sandoz announced that the Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Sandoz’s biosimilars rituximab and etanercept in Europe. If approved, rituximab may be...more

An Opportunity to Shape Compliance with GDPR

by Hogan Lovells on

A close observer of the GDPR will have noticed that, in several places, individual EU Member States can implement derogations from the GDPR requirements. Of course, as a regulation under EU law there is less scope for local...more

Port-of-Entry Inspections and NAFTA Professional (TN) Visas: Differential Diagnosis for Advance Practice Nurses

Since President Trump first issued his executive order suspending travel to the United States by certain foreign nationals, a flood of generalized reports regarding changes to U.S. port-of-entry inspection operations emerged....more

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