On Friday, December 9, more than 100 attendees braved the first major snowstorm of the season to hear presentations from local FDA representatives, as well as leaders from the Rockville headquarters, on emerging regulatory policies and recent enhancements to the agency’s procedures and infrastructure.

Mark Lookabaugh, Director of Compliance for the FDA’s New England District Office, advised attendees on how best to respond to a Form FDA 483 or a warning letter, including successful examples of verbal and written responses for each. Paul Kim, Food and Drug Counsel for Washington, DC-based Foley Hoag LLP, reported on Congress’ intensifying demand for the FDA to improve its post-market device surveillance and to increase public disclosure of device complications and recalls.

The session closed with a presentation by Donna-Bea Tillman, Director of the Office of Device Evaluation at the Center for Devices and Radiological Health (CDRH) on the Center’s efforts to improve review timelines, enhance device surveillance and streamline product submission and reporting processes.

To review the presentations from the FDA Update, please click here.

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