Office of Regulatory Affairs Executive Advisory Council (EAC) Listing
Office of the ACRA
Judy McMeekin, Pharm.D.
Associate Commissioner for Regulatory Affairs
Dr. McMeekin is the Associate Commissioner for Regulatory Affairs (ACRA) within the Office of Regulatory Affairs (ORA) in the Food and Drug Administration (FDA).
Carol Cave
Deputy Associate Commissioner for Regulatory Affairs
Carol Cave is the Deputy Associate Commissioner for Regulatory Affairs (DACRA) in the FDA’s Office of Regulatory Affairs. In this role, she supports the Associate Commissioner for Regulatory Affairs with overseeing inspections, compliance, enforcement, field laboratory operations, import operations, strategic planning, among other areas.
L'Tonya Davis, MPM
Director, Office of Communications and Project Management
L’Tonya Davis is Director of the Office of Communications and Project Management in the Office of Regulatory Affairs (ORA). Ms. Davis is responsible for directing strategic communications operations, and project management operations for ORA. Since December 2015, Ms. Davis has led employee engagement and diversity and inclusion activities in ORA.
Catherine Hermsen
Assistant Commissioner for Criminal Investigations
Cathy Hermsen is the Assistant Commissioner for Criminal Investigations, Office of Criminal Investigations (OCI) within the Office of Regulatory Affairs (ORA) in the Food and Drug Administration (FDA). In this role, Cathy has responsibility for providing direction and oversight within the law enforcement and intelligence arm of the FDA.
Dan Solis
Assistant Commissioner for Import Operations
Michael C. Rogers, MS
Assistant Commissioner for Human and Animal Food
Michael C. Rogers is the Assistant Commissioner for Human and Animal Food (HAF ) operations in the Office of Regulatory Affairs (ORA), focusing on inspection and compliance related issues in the human and animal food programs, overseeing the program directors for east and west HAF operations as well as state cooperative programs. Mr. Rogers joined the FDA in 1991 as a field investigator in the Baltimore District. He then became a supervisory investigator at the Northern Virginia Resident Post, a branch director at FDA headquarters, the director of the Division of Field Investigations, and was later selected as the director of FDA's Latin American Office.
Lisa Romano
Deputy Director, Office of Human and Animal Food Operations
Lisa Creason
Director, Office of Information Systems Management and Associate Deputy CIO in FDA’s Office of Regulatory Affairs
Lisa Creason is the Director of the Office of Information and Systems Management within the Office of Regulatory Affairs (ORA) in the Food and Drug Administration (FDA) and the Associate Deputy Chief Information Officer for ORA.
Glenda Barfell, MS
Assistant Commissioner for Regulatory Operations
Glenda Barfell is the Assistant Commissioner for Regulatory Management Operations within the Office of Regulatory Affairs (ORA), Food and Drug Administration (FDA). She leads a wide range of technical and administrative operations for ORA’s 5,300 managers and employees, including human resources, employee and labor relations, space management for 234 nationwide facilities, performance management, ethics, directing more than 1,000 acquisitions, and is responsible for budget formulation and execution of $1.1B, which includes multiple user fees, programs, project and activities.
Elizabeth Miller, Pharm. D.
Assistant Commissioner for Medical Products and Tobacco Operations
Susan Laska
Deputy Director, Office of Medical Products and Tobacco Operations
Paul E. Norris, DVM, MPA
Director, Office of Regulatory Science
Paul E. Norris is Director of the Office of Regulatory Science (ORS) in the Office of Regulatory Affairs (ORA), Food and Drug Administration (FDA). As ORS director, Dr. Norris provides strategic scientific leadership, coordination, and expertise to ORA laboratories and leaders. He is responsible for providing support for high quality, collaborative, scientific activities that advance regulatory science and address public health issues concerning FDA-regulated products.
Duane Satzger, PhD
Associate Director, Office of Medical Products, Tobacco and Specialty Laboratory Operations
Dan Rice
Associate Director, Office of Food and Feed Laboratory Operations
Erik P. Mettler, MPA, MPH
Assistant Commissioner for Partnerships and Policy
Erik P. Mettler is Assistant Commissioner for Partnerships and Policy within the Office of Regulatory Affairs (ORA) in the Food and Drug Administration (FDA). In this role, he serves as advisor to the Associate Commissioner for Regulatory Affairs on the full range of ORA's activities including partnerships, implementation of new laws and regulations, and overall strategic planning and prioritization. He is responsible for providing long range strategic direction for ORA policies and programs including the implementation of the Food Safety Modernization Act.
Marla Hendriksson
Deputy Director, Office of Partnerships and Operational Policy
Marla Hendriksson is the Deputy Director for the Office of Partnerships and Operational Policy (OPOP) within the Office of Regulatory Affairs in the Food and Drug Administration (FDA).
Steven Tave
Director Office of Strategic Planning and Operational Policy
Steven Tave is the Director for the Office of Strategic Planning and Operational Policy (OSPOP) within the Office of Regulatory Affairs in the Food and Drug Administration (FDA).
Barbara Cassens
Director, Office of Partnerships
Barbara Cassens is the Director for the Office of Partnerships (OP). In her role as the Director of OP, she is responsible for the oversight, strategic planning, collaboration and integration with our federal, state, and local, partners, for manufactured human and animal food safety standards.
Operations Program Directors
Ginette Y. Michaud, MD
Director, Office of Biological Products Operations
Ginette Y. Michaud is the Director of the Office of Biological Products Operations within the Office of Regulatory Affairs (ORA) in the Food and Drug Administration (FDA). She previously served in the Center for Biologics Evaluation and Research as Deputy Director of the Office of Blood Research and Review. Prior to 2009, Dr. Michaud was a regulator at the Center for Devices and Radiological Health, first in the Office of In Vitro Diagnostics and subsequently in the Office of Device Evaluation.
Chrissy Cochran
Director of the Office of Bioresearch Monitoring Operations
Chrissy J. Cochran is Director of the Office of Bioresearch Monitoring Operations within the Office of Regulatory Affairs (ORA) in the Food and Drug Administration (FDA). She is responsible for working with each of FDA’s product centers to establish and manage a new, stand-alone Bioresearch Monitoring Program.
Jan Welch
Director, Office of Medical Device and Radiological Health Operations
Jan Welch serves as Director of the Office of Medical Device and Radiological Health Operations, within the Office of Regulatory Affairs (ORA), Food and Drug Administration (FDA). Ms. Welch leads organizational change to a commodity-based program emphasizing specialization and vertical integration of regulatory processes.
Alonza Cruse
Director, Office of Pharmaceutical Quality Operations
Alonza Cruse is Director of the Office of Pharmaceutical Quality Operations, within the Office of Regulatory Affairs (ORA) in the Food and Drug Administration (FDA). His office is responsible for all pharmaceutical quality inspections and investigations, working in conjunction with FDA’s Center for Drug Evaluation & Research and the Center for Veterinary Medicine. Additionally, Mr. Cruse is leading ORA’s pharmaceutical collaboration efforts under our Program Alignment initiative.
Vinetta Howard-King
Director, Office of Human and Animal Food Operations - East
Vinetta Howard-King is the Director of the Office of Human and Animal Food Operations– East, a program within the Office of Regulatory Affairs (ORA), Food and Drug Administration (FDA). In this role, Ms. Howard-King is responsible for overseeing operational functions (such as: inspections/investigations, sample collections, compliance and enforcement activities) in six HAF field divisions and the HAF foreign inspection program.
Scott MacIntire
Acting Director, Office of Human and Animal Food Operations - West
Vacant
Assistant Commissioner for Compliance and Enforcement
Kara Lynch
Chief of Staff
Diane Goyette
Regulatory Counsel
Matthew Lee
Special Assistant to the ACRA
Syrena Priestley
Executive Assistant
Jeffery Pretti
Senior Advisor
Brittany Shelton
Special Assistant
Sarah Clark-Lynn
Program Manager, Strategic Communication
Kristin McNamara
Program Manager
Thomas Hailey
Program Support Specialist