Contents

SUBCHAPTER 230 - CENTER FOR DRUG EVALUATION AND RESEARCH (CDER)

230 - OFFICE OF THE CENTER DIRECTOR (HFD-1)

Janet Woodcock, M.D. is the CDER Director.

Dr. Murray Lumpkin is the Deputy Center Director for Review Management and the Deputy Center Director for Pharmaceutical Science is currently vacant.

Warren Rumble (HFD-001) is CDER's Ombudsman.

CDER is responsible for developing FDA policy with regard to safety, effectiveness, and labeling of all drug products for human use; reviewing and evaluating new drug applications (NDAs) and investigational new drug applications (INDs); and developing and implementing standards for the safety and effectiveness of all over-the-counter (OTC) drugs. CDER is responsible for monitoring the quality of marketed drug products; developing and promulgating guidelines on Current Good Manufacturing Practices; conducting research and developing scientific standards on the composition, quality, safety, and effectiveness of human drugs. CDER is responsible for collecting and evaluating information on the effects and use trends of marketed drug products; monitoring prescription drug advertising and promotional labeling; and analyzing data on accidental poisonings and disseminating toxicity and treatment information on household products and medicines.

There are three staffs under the immediate office of the Center Director:

1. Regulatory Policy Staff (HFD-7)
   Jane Axelrad, Acting Director
2. Executive Operations Staff (HFD-6)
   Deborah Henderson, Director
3. EEO Staff (HFD-8)
   Diane Smith, Director

The Office of Medical Policy, Robert Temple, MD, Director operates directly under the Center Director. There are two divisions under this office:

1. Div. Of Marketing, Advertising and
   Communications (HFD-40), Norm Drezin, Acting
   Director
2. Division of Scientific Investigations (HFD-340), Joanne Rhoads, MD, Director

231 - OFFICE OF MANAGEMENT (HFD-10) RUSSELL ABBOTT, DIRECTOR

The Office of Management monitors the development and operation of planning systems for resource allocations and information systems; manages studies designed to improve processes and resource allocations; advises the Center on contract and grant proposals; and provides coordination, receipt and distribution of initial drug applications.

There are two divisions and one staff under the Office of Management:

1. Strategic Planning Staff (HFD-10)
   Charlene Cherry, Director
2. Division of Planning, Evaluation, and Resource
3. Division of Management Services (HFD-60)
   Ruth Clements, Director

232 - OFFICE OF INFORMATION TECHNOLOGY (HFD-070)

RALPH LILLIE, DIRECTOR

The Office of Information Technology oversees CDER's installation, maintenance and development of computer systems and databases. There are two staffs and three divisions:

1. Quality Assurance Staff (HFD-070)
   Judy McIntyre, Director
2. Technology Support Services Staff (HFD-070)
   David Moss, Director
3. Division of Infrastructure Management and
   Services (HFD-072), Patrick David, Director
4. Division of Applications Development Services
   (HFD-072), Melissa Chapman, Director
5. Division of Data Management and Services
   (HFD-090), Greg Warzala, Director

233 - OFFICE OF TRAINING AND COMMUNICATIONS (HFD-200)

NANCY SMITH, Ph.D. DIRECTOR

The Office of Training and Communications prepares, develops, and coordinates Center and Agency responses to drug-related requests under the Freedom of Information Act, Privacy Act and other statues. The office provides leadership and direction for all Center internal and external communications; plans coordinates, and evaluates policies, procedures, and programs for the orientation and training of Center staff; and provides scientific and technical resources and other library services.

There is one staff and three divisions under the Office of Training and Communications:

1. Freedom of Information Staff (HFD-200)
   Director - Vacant
2. Division of Training and Development (HFD-220)
   Janice Newcomb, Director
3. Division of Communications Management
   (HFD-210), Ellen Shapiro, Director
4. Division of Medical Library (HFD-230)
   Carol Assoud, Acting Director

234 - OFFICE OF COMPLIANCE (HFD-300),

DIRECTOR - DAVID J. HOROWITZ

The Office of Compliance monitors the quality of marketed drugs through product testing, surveillance, and compliance programs; develops standards for drug industry practices, including Current Good Manufacturing Practice (CGMP) regulations, and ensures their uniform interpretation.

There are three divisions under the Office of Compliance as follows:

1. Division of New Drugs and Labeling Compliance
   (HFD-310), Director - Vacant
2. Division of Manufacturing and Product Quality
   (HFD-320, Director, Joseph C. Famulare
3. Division of Compliance Risk Management and
   Surveillance, (HFD-330), Director - Vacant

235 - OFFICE OF PHARMACEUTICAL SCIENCE, (HFD-3) DEPUTY CENTER

DIRECTOR FOR PHARMACEUTICAL

SCIENCE DIRECTOR - VACANT

The Office of Pharmaceutical Science provides advice and information on pharmaceutical programs and issues; and oversees the development of standards for the safety and effectiveness of generic drugs. OPS oversees the review and evaluation of Abbreviated New Drug Applications (ANDAs), Abbreviated Antibiotic Drug Applications (AADAs), and their amendments or supplements, and determines approvability.

There are two staffs and four offices under the Office of Pharmaceutical Science

1. Product Quality Support Staff
   Vacant, Director
2. Operations Staff (HFD-358)
   Helen Winkle, Acting Director

235.01 - Office of New Drug Chemistry (HFD-800)

Yuan Yuan Chiu, Ph.D., Director

The Office of New Drug Chemistry manages the science issues of chemistry, microbiology, manufacturing and control reviews; and ensures consistency in new drug chemistry reviews; and manages the overall coordination for IND and NDA chemistry and microbiology review processes.

There are three divisions under the Office of New Drug Chemistry:

1. Division of New Drug Chemistry I (HFD-810)
   Charles Hoiberg, Ph.D., Director
2. Division of New Drug Chemistry II (HFD-820)
   John Gibbs, Ph.D., Director
3. Division of New Drug Chemistry III (HFD-830)
   Chi-Wan Chen, Ph.D., Director

235.02 - Office of Generic Drugs (HFD-600),

Gary Buehler, Acting Director

The Office of Generic Drugs oversees the development and implementation of standards for the safety and effectiveness of generic drugs; reviews and evaluates ANDAs and AADAs and the amendments or supplements, and determines approvability; and establishes bioequivalency specifications for drug products.

There are four divisions under the Office of Generic Drugs:

1. Division Of Labeling & Program Support
   (HFD-605) Jerry Philips, Director
2. Division of Chemistry I (HFD-620)
   Rashmikant Patel, Ph.D., Director
3. Division of Chemistry II (HFD-640)
   Frank Holcombe, Jr., Ph.D., Director
4. Division of Bioequivalence (HFD-650)
   Nicholas Fleischer, Ph.D., Director

235.03 - Office of Testing and Research (HFD-900)

James MacGregor, Ph.D.,

Director

The Office of Testing and Research conducts research and develops scientific standards on the composition, quality, safety, and effectiveness of human drug products.

There is one staff, one laboratory, and three divisions under the Office of Testing and Research:

1. Regulatory Research and Analysis Staff
   (HFD-901) Joseph Contrera, PhD, Director
2. Laboratory of Clinical Pharmacy (HFD-902)
   Jerry Collins, Ph.D., Director
3. Division of Product Quality Research
   (HFD-940) Karl Flora, Ph.D., Director
4. Division of Applied Pharmacology Research
   (HFD-910) Frank Sistare, Ph.D., Director
5. Division of Testing and Applied Analytical
   Development (HFD-920) Moheb Nasr, Ph.D.,
   Director

235.04 - Office of Clinical Pharmacology & Biopharmaceutics (HFD-850)

Larry Lesko, PhD, Director

The Office of Clinical Pharmacology & Biopharmaceutics evaluates pharmacokinetic, pharmacodynamic, bioavailability, bioequivalence, and drug metabolism protocols and data in notices of claimed investigational exemption for INDs, NDAs, antibiotic applications, and their supplements and amendments.

There is one staff and three divisions under the Office of Clinical Pharmacology & Biopharmaceutics:

1. Pharmacometrics Staff (HFD-851)
   William Gillespie, Ph.D., Acting Director
2. Division of Pharmaceutical Evaluation I (HFD-860)
   Hank Malinowski, Ph.D., Director
3. Division of Pharmaceutical Evaluation II (HFD-870)
   Mei Ling Chen, Ph.D., Director
4. Division of Pharmaceutical Evaluation III
   (HFD-870) John Lazor, Ph.D. Acting Director

236 - OFFICE OF REVIEW MANAGEMENT (HFD-20)

MURRAY LUMPKIN, DEPUTY

DIRECTOR

The Office of Review Management develops and implements the Center's review management and scientific policies, including user fee policies, pertaining to the drug review process.

There are three staffs and seven offices under the Office of Review Management:

1. Advisors and Consultants Staff (HFD-21)
   John Treacy, Director
2. Program Management Team (HFD-022)
   William Oswald, Team Leader
3. Reports and Data Management Team (HFD-023)
   Ann Myers, Team Leader
4. Pharmacology/Technology Staff (HFD-024)
   Joseph DeGeorge, Ph.D., Team Leader

236.01 - Office of Drug Evaluation I (HFD-101)

Robert Temple, MD

This office reviews notices of claimed investigational exemptions for new drugs (INDs) within classes of drugs regulated by this Office and recommends appropriate action with respect to safety and effectiveness of clinical trials. Evaluates for safety and effectiveness and approves new drug applications (NDAs) for products regulated by this Office, and evaluates supplements proposing changes in the conditions upon which NDA approvals are based.

There are three divisions in this Office as follows:

1. Division of Neuropharmacological Drug Products
   (HFD-120) Russ Katz, MD, Director
2. Division of Oncologic Drug Products (HFD-150)
   Robert Justice, MD, Director
3. Division of Cardio-Renal Drug Products (HFD-110)
   Raymond Lipicky, MD, Director

236.02 - Office of Drug Evaluation II (HFD-102)

John Jenkins, MD, Director

This office reviews notices of claimed investigational exemptions for new drugs (INDs) within classes of drugs regulated by this Office and recommends appropriate action with respect to safety and effectiveness of clinical trials. Evaluates for safety and effectiveness and approves new drug applications (NDAs) for products regulated by this Office, and evaluates supplements proposing changes in the conditions upon which NDA approvals are based.

There are three divisions in this Office as follows:

1. 1. Division of Metabolic & Endocrine Drug Products
   (HFD-510) Solomon Sobel, MD, Director
2. 2. Division of Pulmonary Drug Products (HFD-570)
   Robert Meyer, MD, Acting Director
3. 3. Division of Reproductive and Urologic Drug
   Products (HFD-580) Lisa Rarick, MD, Director

236.03 - Office of Drug Evaluation III (HFD-103)

Florence Houn, MD, Director

The Office of Drug Evaluation III reviews notices of claimed investigational exemptions for new drugs (INDs) within classes of drugs regulated by this Office and recommends appropriate action with respect to safety and effectiveness of clinical trials. They evaluate for safety and effectiveness and approve new drug applications (NDAs) for products regulated by this Office, and evaluate supplements proposing changes in the conditions upon which NDA approvals are based.

There are three divisions in this office as follows:

1. Division of Gastrointestinal & Coagulation Drug
   Products (HFD-180) Lilia Talarico, MD, Director
2. Division of Anesthetic, Critical Care, & Addiction
   Drug Products (HFD-170) Cynthia McCormick,
   MD, Acting Director
3. Division of Medical Imaging & Radiopharma-
   ceutical Drug Products (HFD-160)
   Patricia Love, MD, Director

236.04 - Office of Drug Evaluation IV (HFD-104)

Sandra Kweder, MD, Acting Director

The Office of Drug Evaluation IV reviews notices of claimed investigational exemptions for new drugs for (INDs) within classes of drugs regulated by this Office and recommends appropriate action with respect to safety and effectiveness of clinical trials. The office evaluates for safety and effectiveness and approves new drug applications (NDAs) for products regulated by this Office, and evaluates supplements proposing changes in the conditions upon which NDA approvals are based.

There are three divisions in this office as follows:

1. Division of Anti-Infective Drug Products (HFD-520)
   Gary Chikami. MD, Director
2. Division of Anti-Viral Drug Products (HFD-530)
   Heidi Jolson, MD, Acting Director
3. Division of Special Pathogen and Immunologic
   Drug Products (HFD-590) Mark Goldberg, MD,
   Director

236.05 - Office of Drug Evaluation V (HFD-105)

Robert DeLap, MD, Director

This office reviews notices of claimed investigational exemptions for new drugs (INDs) within classes of drugs regulated by this Office and recommends appropriate action with respect to safety and effectiveness of clinical trials. This office evaluates for safety and effectiveness and approves new drug applications (NDAs) for products regulated by this Office, and evaluates supplements proposing changes in the conditions upon which NDA approvals are based.

There are three divisions in this Office as follows:

1. 1. Division of Anti-Inflammatory, Analgesic &
   Ophthalmologic Drug Products (HFD-550)
   Director Vacant
2. 2. Division of Dermatologic & Dental Drug Products
   (HFD- 540) Jonathan Wilkin, MD, Director
3. 3. Division of Over-the-Counter Drug Evaluation
   (HFD-560) Charles Ganley, MD, Director

236.06 - Office of Biostatistics (HFD-700)

Robert O'Neill, Ph.D., Director

The Office of Biostatistics conducts programs to collect and evaluate epidemiological and non-epidemiological information on drug and biological product usage, adverse reactions, poisonings, safety, quality, and effectiveness.

There is one staff and three divisions under the Office of Biostatistics:

1. Quantitative Methods Research Staff (HFD-705)
   Stella Machado, Ph.D., Director
2. Division of Biometrics I (HFD-710)
   George Chi, Ph.D., Director
3. Division of Biometrics II (HFD-715)
   S. Edward Nevius, Ph.D., Director
4. Division of Biometrics III (HFD-720)
   Mohammed Huque, Ph.D., Director

236.07 - Office of Post Marketing Drug Risk

Assessment (HFD-730)

Murray Lumpkin, Acting Director

This office is responsible for obtaining and evaluating post-market information on approved NDAs, ANDAs, INDs, etc.

There are two staffs and two divisions under the Office of Post Marketing Drug Risk Assessment:

1. Extramural Program Staff (HFD-730)
   Tom Conrad
2. Information Technology Staff (HFD-730)
   William Calvert
3. Division of Drug Risk Evaluation I (HFD-730)
   Peter Honig, MD, Director
4. Division of Drug Risk Evaluation II (HFD-730)
   Evelyn Rodriguez

240 - OFFICE OF THE CENTER DIRECTOR

David Feigal, MD is the Center Director of CDRH. Linda Kahan is the Deputy Center Director of CDRH. Lillian J. Gill is the Senior Associate Director of CDRH.

The Center for Devices and Radiological Health (CDRH) develops and carries out a national program to assure the safety, effectiveness, and labeling of medical devices for human use. It reviews and evaluates medical device pre-market approval applications (PMA's), product development protocols (PDP's), exemption requests for investigational devices (IDE's), and premarket notifications [510(k)'s].

The Center provides technical and other nonfinancial assistance to small manufacturers of medical devices.

CDRH develops and carries out a national program designed to control unnecessary exposures of humans to, and assure the safe and efficacious use of, ionizing and non-ionizing radiation-emitting electronic products.

CDRH has about 1000 employees.

The Office of the Center Director, in addition to providing overall leadership and direction for the Center, provides advice and consultation to the Commissioner and other Agency officials on policy matters concerning radiological health and medical device activities. The office recommends changes in legislative authority to the Commissioner, establishes policy in the areas of education and communications, and formulates strategies for developing and disseminating educational and programmatic information to health professionals, consumers, and other government agencies. The office plans and coordinates the Center's equal employment opportunity programs.

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