Uncategorized

What Irish and Northern Irish Companies Need to Know Now: Doing Business in the U.S.–Free Webinar

Mike Burke Uncategorized

Mike Burke's avatarIrish Export Insights

Thursday, June 30, 2016 at 3:00 pm Dublin/Belfast.

The attorneys of Arnall Golden Gregory’s International Business Practice invite you to attend a complimentary, 60-minute webinar “What Irish and Northern Irish Companies Need to Know Now: Doing Business in the U.S.” The webinar will be held Thursday, June 30, 2016 at 10:00 am EDT (3:00 pm Dublin/Belfast). The United States is an attractive, and expanding, market for Irish and Northern Irish goods and services. Despite suggestions to the contrary, the U.S. can be an easy market for business expansion—with a little bit of planning. This webinar will examine key legal issues for doing business in the U.S., including:

  • Protecting the Irish and Northern Irish parent company, its investors, and capital from U.S. legal risk;
  • Avoiding branch profits tax issues;
  • Reducing payment risk by ensuring prompt payment from customers, and other U.S. contract essentials;
  • The product liability risks that may attach…

View original post 127 more words

Expert Webinar on FDA Off-Label Communications Regulations

Mike Burke Uncategorized , , , , , , , , , , , ,

The US FDA’s regulation of ‘off-label communications’ (communications about the use of FDA-approved pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration) can be complex and confusing, especially for Irish and Northern Irish life sciences companies marketing/distributing their product in the US. Recent FDA actions have muddied the waters a bit more. Without clear guidance from the FDA , life sciences companies are struggling to decide how best to approach off-label communications, if at all. Continue reading →

Critical Changes to US Visa Waiver Program Impact Irish/NI Companies

Mike Burke Employment, Immigration, Uncategorized , , , , , , , , , , , , ,

Bottom line up front: as of last Friday, new changes to the US’s Visa Waiver program restrict the use of that program by persons who have visited Iran, Iraq, Syria, or the Sudan at any time after March 1, 2011. Additional “countries of concern” may be added to this list. The nationality of the traveler is not an issue, so this change impacts any person traveling on an Irish or UK passport who has been to the listed countries in the relevant timeframe. Continue reading →