In the Know

What Irish/Northern Irish Companies Need to Know Now: Working with the U.S. Food and Drug Administration
AGG Seminars & Webinars
November 4, 2014

The attorneys of Arnall Golden Gregory LLP's Food and Drug and International Business Practices invite you to attend a complimentary, 60-minute webinar, “What Irish/Northern Irish Companies Need to Know Now: Working with the U.S. Food and Drug Administration.” The webinar will be held Tuesday, November 4, 2014 at 10:00 am EDT (3:00 pm Dublin/Belfast).

Many Irish and Northern Irish companies must interact with the U.S. Food and Drug Administration (FDA) in order to introduce or keep their products in the U.S. Navigating this regulatory pathway requires not only an understanding and appreciation of applicable statutory and regulatory requirements, but knowledge of basic policies, sometimes unwritten, that drive decision-making at the FDA.

This webinar will provide best practices in dealing with the FDA in key areas, such as:

  • product development and marketing authorization strategies; 
  • product safety and effectiveness standards; 
  • product quality assurance; 
  • product advertising and promotion controls; and
  • post-market surveillance.

Register now to hear AGG Partners Alan Minsk and Michael Burke discuss business sensible and enterprising approaches to accessing the US market and working with the FDA.