Expert Webinar on FDA Off-Label Communications Regulations

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

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

A Holiday Gift: Making Lawsuits Speedier and Less Expensive

Even though it is the holiday season, nobody wants to get or give the ‘gift’ of civil litigation in a US Federal court. Not even a lawyer (I’m personally hoping for tickets to Bruce Springsteen’s new River tour, but I digress). I have spent a bit of virtual ink on this blog writing about how Irish and Northern Irish companies can avoid going to a US courthouse (I used a fancy phrase like ‘mitigate US litigation risk’), and I stand by that guidance. But if you do find yourself in a US Federal Court, some new amendments to the Federal Rules of Civil Procedure aim to make civil suits speedier and less expensive.  My colleague Ed Cadagin has written a client update on these amendments.  The takeaways: the revised rules (i) shorten the timelines for actions such as serving the defendant and issuing scheduling orders; and (ii) limit discovery to that which is “proportional to the needs of the case,” replacing the former discovery standard of “reasonably calculated to lead to the discovery of admissible evidence.” Ed’s full client alert can be read here. If you have to litigate here (and there will be times where US litigation is necessary), these rules should help make the experience more efficient for Irish and Northern Irish litigants.