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!