FDA

Do You Want a .health Domain Name?

Mike Burke Intellectual Property, Life Sciences , , , , , , , , ,

As Irish and Northern Irish companies expand to the U.S., they need to make a decision or two about the company’s (or the US affiliate’s) domain name.  Companies that provide health products, services, and/or information–life sciences companies–can register for a ‘.health’ domain name from and after December 5, 2017. But registering for a ‘.health’ domain name can also present challenges to trademark owners in protecting their intellectual property. This is a great article from my colleagues Tucker Barr and Sean Sullivan on the subject: http://www.agg.com/do-you-want-a-health-web-domain-name-do-you-want-to-prevent-others-from-using-your-trademark-in-a-health-web-domain-name-05-02-2017/. Take a look!

 

 

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 →

Newest FDA Newsletter from AGG

Mike Burke Life Sciences ,

Once a month, AGG’s terrific FDA team publishes a newsletter updating readers on the latest regulatory news affecting food/drug companies–including those from Ireland and Northern Ireland. The August newsletter is here and has several updates of interest for Irish and Northern Ireland life sciences companies operating, or looking to operate, in the US: (i) additional discussion of the Amarin off-label promotion case; (ii) guidance for data-driven medical device companies on implementing effective data security and privacy measures; and (iii) potential changes that could streamline 510(k) medical device reviews at FDA. If you have questions or comments about the newsletter, please contact me or the author(s) of the articles in question.

Happy reading!