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  1. Office of Global Regulatory Operations and Policy

Office of Regulatory Affairs Executive Advisory Council (EAC) Listing

Office of the ACRA

Melinda Plaisier

Melinda K. Plaisier, MSW
Associate Commissioner for Regulatory Affairs

Melinda Plaisier is Associate Commissioner for Regulatory Affairs (ACRA). She has responsibility for over 5,000 staff and operations in the Office of Regulatory Affairs (ORA) in the Food and Drug Administration (FDA).

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Judy McMeekin

Judy McMeekin, Pharm.D.
Deputy Associate Commissioner for Regulatory Affairs

Judy McMeekin is the Deputy Associate Commissioner for Regulatory Affairs (DACRA) within the Office of Regulatory Affairs (ORA) in the Food and Drug Administration (FDA).

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L'Tonya Davis

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.

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Catherine Hermsen

Catherine Hermsen
Director, Office of Criminal Investigations

Catherine Hermsen is the Director of the 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. 

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Carol Cave

Carol Cave
Director, Office of Enforcement and Import Operations

Ms. Cave serves as the director of the Office of Enforcement and Import Operations and has responsibility for providing direction and oversight of the Food and Drug Administration’s field import operations. This includes reviewing prior notice and intelligence data on human and animal food and leading the development, implementation, and evaluation of laws, regulations, and policies as they related to broad global and national programs and activities.

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Michael Rogers

Michael C. Rogers, MS
Assistant Commissioner for Human and Animal Food Operations

Michael C. Rogers is the acting 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.

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Glenda Barfell

Glenda Barfell, MS
Director, Office of Management

Glenda Barfell is the director of the Office of Management in the Office of Regulatory Affairs (ORA), Food and Drug Administration (FDA). She is responsible for a wide range of technical and administrative services, including human resource and performance management, budget formulation and execution, travel, and contracts and grants.

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Ellen Morrison

Ellen F. Morrison
Assistant Commissioner for Medical Products and Tobacco Operations

Ms. Morrison is the assistant commissioner for medical products and tobacco operations (ACMPTO) in the Office of Regulatory Affairs (ORA) at the Food and Drug Administration (FDA) leading a team that serves as focal point for coordination and management of ORA’s medical product and tobacco field activities.

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Paul Norris

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.

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Barbara Cassens

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.

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Barbara Cassens

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.

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CAPT Laura Draski
Acting Director, Office of Strategic Planning and Operational Policy

 

 

Operations Program Directors

Ginette Michaud

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.

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Chrissy Cochran

Chrissy Cochran
Director, 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. 

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Jan Welch

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. 

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Alonza Cruse

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.

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Vinetta Howard-King

Vinetta Howard-King
Acting Director, Office of Human and Animal Food Operations - East

Vinetta Howard-King is the acting 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.

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Joann M. Givens

Joann M. Givens
Director, Office of Human and Animal Food Operations - West

Joann M. Givens serves as director of the Office of Human and Animal Food Operations-West, within the Office of Regulatory Affairs (ORA), Food and Drug Administration (FDA). In this leadership position, Ms. Givens oversees the human and animal food program work plan, accomplishments, implementation strategies for the Food Safety Modernization Act, and program alignment advancement. She also collaborates with the Center of Food Safety and Applied Nutrition, the Center of Veterinary Medicine, ORA components, and external stakeholders.

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Amy Folden
Special Assistant to the ACRA

Lauren Franz
Special Assistant to the ACRA

Kara Lynch
Science Policy Analyst to the ACRA

Kristin McNamara
Program Manager to the ACRA

Laura Ortiz
Program Manager to the ACRA