Header graphic for print

Focus on Regulation

New FAA-Commissioned Report on Unmanned Aircraft Systems (UAS) Human Collision Hazards May Support Broader Approval for UAS Flights Over People

Part 107, the rule broadly authorizing commercial UAS (drone) operations, was an important step forward for the commercial UAS industry.  However, Part 107 limited operations in important ways.  One significant limitation surrounds flights over people.  Under current FAA regulations, flights over people other than the UAS flightcrew are prohibited.  This prohibition creates significant obstacles for commercial UAS operators, especially those that typically need to occur in more urban and suburban environments, such as media and newsgathering activities, real estate, infrastructure inspection and, someday, package delivery, will require the flexibility to operate over people. Continue Reading

Confidentiality Agreement Rule Poses New HR-related Compliance Burden for Contractors

*Associate Ryan Harrigan also contributed to this post

While contractors (and their HR departments) dodged a serious bullet with Trump’s recent invalidation of the 2016 FAR blacklisting rule, they need to be alert to a new HR-related compliance requirement as a result of a rule promulgated on the final day of the Obama Administration.

The Substance of the Rule:

The rule, which became effective on January 19, 2017, prohibits Federal contractors from requiring employees or subcontractors to comply with internal confidentiality agreements that restrict “lawfully reporting waste, fraud, or abuse related to the performance of a government contract.”  Federal Acquisition Regulation (FAR) 52.203-19; 82 Fed. Reg. 4717-01.  The rule requires Federal agencies to include the following provisions in new solicitations and existing contracts that are funded with fiscal year (FY) 2015 funds or subsequent FY funds:

  • FAR 52.203-18: Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or Statements—Representation; and
  • FAR 52.203-19: Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements.

Continue Reading

Your Newest Instagram Follower, the FTC: Agency Reminds Endorsers and Marketers to #Disclose with Over 90 Warning Letters

The Federal Trade Commission (FTC) reminded celebrities, social media influencers, and marketers that failing to disclose material connections to the products they endorse is #notokay. On April 19, 2017, the FTC sent over 90 letters to such personalities and businesses stating that they must clearly and conspicuously disclose commercial relationships when promoting or endorsing products.

Click here to read more.

Congress Eliminates Obama-Era Regulations on Teacher Preparation Programs

President Trump signed into law on March 27 a joint resolution to nullify U.S. Department of Education (ED) regulations relating to teacher preparation programs pursuant to the Congressional Review Act (CRA).  As noted in its Statement of Administration Policy, the White House “strongly supports the actions taken . . . to begin to nullify unnecessary regulations” and highlighted the rule on teacher preparation programs as one that “impose[d] new burdensome and costly data reporting requirements on States and institutions of higher education.”

Continue Reading

General Election 2017: Comply with the Campaigning Rules

The 2017 General Election campaign is up and running.  There are strict rules on campaign spending by non-political parties during the 365 days leading up to a General Election, which apply retrospectively back to 9 June 2016 until 8 June 2017.  With businesses engaging with the British public about important political issues like never before, they will need to ensure that past and future publications, events and other activities during the regulated period do not inadvertently breach the widely-drafted regulations on controlled expenditure.  Read the full blog here.

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.

Continue Reading

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.

Continue Reading