The Center For Drug Evaluation and Research’s newly reorganized Office of Compliance includes four subordinate offices, three of which are similar in function to their predecessor divisions. The Office of Drug Security, Integrity & Recalls is a new entity that houses the imports group formerly located in the Division of New Drugs & Labeling Compliance. The former Division of Compliance Risk Management & Surveillance did not survive the reorganization intact; rather, its functions have been elevated and integrated throughout the Office of Compliance. Below are the old and new organizational structures and leaders for the Office of Compliance. Information on the previous structure was drawn from CDER’s listing of key officials, updated as of May 26. Details about the new structure were provided by CDER.
Previous Organization	New Organization (as of 6/6/2011)
OC/Immediate Office	OC/Immediate Office
Director, Deborah Autor Deputy Director, Ilisa Bernstein (acting) Assistant Director, Douglas Stearn Associate Director of Scientific and Medical Affairs, Stephen Grant Associate Director for Risk Analysis and Strategic Planning, Gregg Claycamp Associate Director of Operations, Kristi Hampton-Thurston Associate Director of Business Operations, Daniel Nguyen, Collin Figueroa (Acting)	Director, Deborah Autor (acting) Deputy Director for Program Operations, Ilisa Bernstein Deputy Director for Policy & Analysis, Douglas Stearn Associate Director for Risk Science, Intelligence & Prioritization, Gregg Claycamp (acting) Associate Director for Organizational Strategy, Kristi Hampton-Thurston Associate Director for Business & Administration, Collin Figueroa
Division of Compliance Risk Management & Surveillance	Office Of Drug Security, Integrity & Recalls
Director, Gregg Claycamp Deputy Director, Karen Kirchberg Project Management Officers, Carl Huntley, Tamika White Surveillance and Data Analysis Branch, Jerry Yokoyama (acting) Risk Management and Strategic Problem Solving Team, Suzanne Barone Surveillance Programs Team, Elise Murphy Data Analysis and Information Management Team, Lakshmi Cherukuri (acting) Drug Registration & Listing Team, Paul Loebach	Director, Michael Levy (acting) Deputy Director, vacant Associate Director for Program Management & Organizational Strategy, Danny Nguyen (acting) Associate Director for Risk Science, Intelligence & Prioritization, Steve Wolfgang (acting) Associate Director for Policy & Communication, Connie Jung (acting) Division of Import Operations & Recalls, director, vacant Recalls Coordination Branch, Israel Santiago (acting) Import Operations Branch, Huascar Batista (acting) Division of Supply Chain Integrity, deputy director, Leigh Verbois (acting)
Division of Manufacturing & Product Quality	Office of Manufacturing & Product Quality
Director, Rick Friedman Deputy Director, Michael Smedley Associate Director for Drug Quality Assurance, vacant Associate Director for Regulatory Science, vacant Associate Director, vacant Project Management Officers, Kennerly Chapman, Helen Saccone, Keith Olin Guidance and Policy Development Team, Brian Hasselbalch Recalls and Shortages Branch, Steven Lynn Recalls and Shortages Team I, William Fritsch Recalls and Shortages Team II, Israel Santiago Data Analysis Team, Steve Wolfgang (acting) Manufacturing Assessment and Preapproval Compliance Branch, Barry Rothman (acting) New and Generic Drug Manufacturing Team I, Tara Gooen New and Generic Drug Manufacturing Team II, Concepción Cruz Biotech Manufacturing Team, Patricia Hughes Domestic Case Management Branch, Teddi Lopez Domestic Case Management Team I, Rosa Motta (acting) Domestic Case Management Team II, David Jaworski (acting) International Compliance Branch, Carmelo Rosa (acting) International Compliance Team I, Carmelo Rosa International Compliance Team II, vacant	Director, Steven Lynn (acting) Deputy Director, Michael Smedley (acting) Associate Director for Program Management & Organizational Strategy, Kennerly Chapman (acting) Associate Director for Risk Science, Intelligence & Prioritization, Rick Friedman (acting) Associate Director for Policy & Communication, Helen Saccone (acting) Associate Director for Drug Quality Assurance, vacant Division of International Drug Quality, director, Carmelo Rosa (acting) International Compliance Branch 1 International Compliance Branch 2 Division of Domestic Drug Quality, director, Teddi Lopez (acting) Domestic Compliance Branch 1 Domestic Compliance Branch 2 Division of Policy, Collaboration & Data Operations, director, Michael Smedley (acting) Drug Surveillance and Data Reporting Branch Regulatory Policy and Collaboration Branch Division of Good Manufacturing Practice Assessment, director, Barry Rothman (acting) Biotech Manufacturing Assessment Branch New Drug Manufacturing Assessment Branch Generic Drug Manufacturing Assessment Branch
Division of Scientific Investigations	Office of Scientific Investigations
Director, Leslie Ball Deputy Director, Joseph Salewski Associate Director, CT Viswanathan Project Management Officers, Chris Howard (acting), Tanya Clayton Human Subject Protection Team, Kevin Prohaska (acting) International Policy Team, Alex Gorovets (acting) Good Clinical Practice Branch I, Constance Lewin Good Clinical Practice Team I, Sherbet Samuels (acting) Good Clinical Practice Branch II, Tejashri Purohit-Sheth Good Clinical Practice Team II, Jean Mulinde (acting) Good Laboratory Practice and Bioequivalence Investigations Branch, Sam Haidar (acting) Bioequivalence Team, Martin Yau (acting) Good Laboratory Practice Team, Jackie O’Shaughnessy (acting) Information and Informatics Team, Thomas Moreno (acting)	Director, Leslie Ball (acting) Deputy Director, Tom Moreno (acting) Associate Director for Program Management & Organizational Strategy, vacant Associate Director for Risk Science, Intelligence & Prioritization, Ann Meeker-O’Connell (acting) Associate Director for Policy & Communication, Karena Cooper (acting) Division of Bioequivalence and Good Laboratory Practice Compliance, director, Joseph Salewski (acting) Bioequivalence Branch Good Laboratory Practice Branch Division of Good Clinical Practice Compliance, director, Tejashri Purohit-Sheth (acting) GCP Enforcement Branch GCP Assessment Branch Division of Safety Compliance, director, Kevin Prohaska (acting) Post Market Safety Branch Human Subject Protection Branch
Division of New Drugs & Labeling Compliance	Office of Unapproved Drugs & Labeling Compliance
Director, Michael Levy Deputy Director, Kathleen Anderson Associate Director, Gail Bormel Project Management Officers, Akilah Green, Alisea Crowley OTC Drug Team, Robert Heller, Anuj Shah Internet and Health Fraud Team, Elizabeth Miller Pharmacy Compounding Team, Samia Nasr New Drug Labeling Team, Judith McMeekin Imports and Exports Team, Huascar Batista	Director, Kathleen Anderson (acting) Deputy Director, vacant Associate Director for Program Management & Organization, Akilah Green (acting) Associate Director for Risk Science, Intelligence & Prioritization, Meghan Murphy (acting) Associate Director for Policy & Communication, Gail Bormel (acting) Division of Prescription Drugs, director, Judith McMeekin (acting) Prescription Drugs Branch Compounding and Pharmacy Practices Branch Division of Non-Prescription Drugs & Health Fraud, director, Elizabeth Miller (acting) Over-the-Counter Drugs Branch Health Fraud and Consumer Outreach Branch

CDER’s New “Super-Office” Of Compliance

More from Archive

More from Pink Sheet