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Focus on Regulation

New E.O. Reinforces President Trump’s “Buy American” Agenda

On April 18, 2017, President Donald Trump signed the executive order “Buy American and Hire American” aimed at maximizing the federal government’s use of goods, products, and materials produced in the United States.  The E.O. does not attempt to change existing law, but requires agencies to increase monitoring, enforcement, and compliance with Buy American Laws while minimizing the use of waivers.  The order also focuses on President Trump’s policy to protect the interests of United States workers and “Hire American.”  With an emphasis on the Trump Administration’s “Buy American” agenda, it will be more critical than ever for federal contractors and grantees to focus on their own compliance with domestic preference requirements. Continue Reading

Finger on the polls – May calls for snap General Election

UK Prime Minister Theresa May has today announced that she intends to trigger a General Election to take place on 8 June 2017. The announcement is the latest unexpected twist in an unpredictable 12 months in British politics.  What does this surprise development mean for the Brexit process?  Read the full blog here.

EMA seeks to support the use of patient registries and to improve dialogue between various stakeholders

 

In September 2015, the European Medicines Agency (EMA) launched the initiative for patient registries. The purpose of the initiative is to improve the benefit-risk evaluation of medicinal products for human use. The EMA’s initiative for patient registries focuses mainly on the ways in which existing patient registries could be improved. This could be systematically considered by regulators and pharmaceutical companies when collecting regulatory data.

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European Commission publishes recommendations concerning the summary of product characteristics and patient information leaflet for medicinal products

 

The European Commission (EC) has published a report (Report) recommending improvements in the summary of product characteristics (SmPC) and the Patient Information Leaflet (PIL) of medicinal products for human use. The report identifies shortcomings concerning the SmPC and the PIL, and provides recommendations on the way in which SmPC and PIL could be improved.

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Regional Accrediting Agency Proposes Ban on Paying Recruiters of International Students

On March 27, the Middle States Commission on Higher Education (“Middle States”) released for public comment a draft policy on its expectations for honesty and truthfulness in published information and in student recruitment practices. Among other things, the policy would prohibit Middle States-accredited institutions from paying commissions to agents to recruit international students. Middle States is accepting public comment on the policy through April 17, 2017. Continue Reading

Sky full of drones – Germany opens up for new drone opportunities as it introduces its new UAS Regulation

Germany has introduced a new “Regulation for the Operation of Unmanned Aircraft Systems” (“Drone-Regulation“). On 7 April 2017, the new Drone-Regulation entered into force adapting national legislation to the risk-based approach of the European Union and setting the way for innovative technologies. However, the new rules also contain identification and qualification obligations as well as strict authorisation requirements for specific operations of Unmanned Aircraft Systems (“UAS”).

Some aspects of Germany’s new UAS regulations parallel the Federal Aviation Administration’s (“FAA”) Small UAS Rule (Part 107) that went into effect in the United States last August. Similar to the rules adopted by the FAA, Germany’s new UAS regulations place general restrictions on operating UAS beyond visual line of sight (“BVLOS”) and limit operations over people. Notably, however, Germany’s new regulations also provide a pathway for authorizing more advanced commercial UAS operations that go beyond the scope of the regulations in circumstances where it is safe to do so. This is similar to the waiver process adopted by the FAA in Part 107 for authorizing operations beyond the scope of the rule. Continue Reading

Court Upholds DOJ Antitrust Lawsuit Challenging Carolinas HealthCare System’s Anti-Steering Provisions

Despite a recent decision by the Second Circuit suggesting that anti-steering contractual provisions in other industries may not be anticompetitive, DOJ’s lawsuit (United States v. Carolinas HealthCare System) against Carolinas HealthCare System’s (CHS’s) contracting practices continues forward after surviving a motion for judgment on the pleadings. On March 30, a North Carolina federal judge found that DOJ’s lawsuit targeting CHS’s direct and indirect anti-steering provisions preventing insurers from steering patients to lower-cost providers alleged plausible antitrust violations and should continue to discovery.

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From Garage to Global Coverage: SmallSat Growth and Opportunities are the Focus of the 2017 SmallSat Symposium and CSSMA Meeting

Welcome signs greet participants at the 2017 Satellite Symposium.

Welcome signs greet participants at the 2017 Satellite Symposium.

At this year’s SmallSat Symposium in Silicon Valley, February 6-8, 2017, attendees exchanged perspectives on promoting innovation and development in the satellite industry, all surrounded by exhibits of the first computers and early innovators who paved the way.  Due to attendance twice as high as last year’s event, the SmallSat Symposium experienced a slight upgrade—the event was moved from last year’s tent in the Hogan Lovells, Menlo Park parking lot to the Computer History Museum in Mountain View.  This dramatic increase in attendance is just one indicator of the significant growth the SmallSat industry is experiencing.
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The MHRA issues new guidance concerning Own Brand Labelling or “Virtual Manufacturing”

On 29 March 2017, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published a new guidance (hereafter “Guidance“) concerning the Own Brand Labelling of medical devices in the United Kingdom. The Guidance, which is expected to have substantial consequences for the current arrangements between Own Brand Labellers (OBL) and “Original Equipment Manufacturers” (OEM), is intended to replace the MHRA guidance titled “Own Brand Labelling and Rented Products, Bulletin No. 19” last amended in June 2011.

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