Honesty Is Hardly Ever Heard, and Mostly What FDA Needs From Your Firm: Handling a Regulatory Call or Meeting with FDA

Event Details

Please join Food & Drug practice team leader Alan G. Minsk and of counsel and former Acting and Deputy Director of FDA’s Office of Dietary Supplement Programs Robert Durkin for a complimentary webinar on how pharmaceutical, biologic, medical device, and food companies can handle a regulatory call or meeting with the Food and Drug Administration. These meetings discuss compliance concerns, typically relating to quality-related issues that FDA perceives could possibly cause harm to consumers of the company’s FDA-regulated products. Depending on a number of factors, there may be a potential opportunity for the company to extricate itself from a near-fatal experience or it can accelerate the company into a likely enforcement action, such as a consent decree or some other similarly devastating consequence.

This webinar will focus on a variety of topics, including:

• high-level themes and specific items that companies should remember and follow that promote success and, conversely, maximize failure if not considered;
• the AGG attorneys’ collective experience on how companies should prepare and act before, during, and after the meeting; and
• proactive steps to be taken that can increase the likelihood of achieving the best result possible.

There will be an opportunity for Q&A at the end of this webinar.

Credits: 1 hour of CLE credit is pending approval by the State Bar of Georgia.