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.
On Wednesday March 30, two of my colleagues, Alan Minsk and Kelley Nduom, will host a one-hour webinar: “Off-Label Promotion: A Crystal Ball Look at Possible Effects of Recent Developments Developments in This Ever-Evolving Area.” The webinar will start at 11:30AM on the US East Coast, 4:30PM in Dublin/Belfast (if I’m understanding daylight savings time correctly). The webinar is free, but you have to register by clicking here. Alan and Kelley are terrific speakers and experts in this field, and I’d encourage every Irish and Northern Irish life sciences company to register.