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  1. CDER Offices and Divisions

Office of Generic Drugs | Offices and Divisions

Immediate Office (IO)

Iilun C. Murphy, M.D., Director, Office of Generic Drugs (OGD)

Darby Kozak, PhD, Deputy Director

Kendra Stewart, R.Ph., Pharm.D., Deputy Director for Operations

Sarah Ibrahim, Ph.D., Associate Director for Stakeholder and Global Engagement Tawni Schwemer, CCMP, GWCPM, Senior Advisor to the OGD Office Director

Tawni Schwemer, CCMP, GWCPM, Senior Advisor to the OGD Office Director

The IO provides oversight, leadership, strategic direction, and support for the Office of Generic Drugs (OGD) and its five sub-offices: Office of Bioequivalence, Office of Generic Drug Policy, Office of Regulatory Operations, Office of Research and Standards, and Office of Safety and Clinical Evaluation.

The Immediate Office also includes the:

COMMUNICATIONS STAFF - Oversees and coordinates all communications that originate from OGD, ensuring consistency and accuracy, and serves as media liaison to CDER’s Office of Communications and FDA’s Office of Media Affairs.

GLOBAL GENERIC DRUG AFFAIRS TEAM – Coordinates and supports OGD’s global engagement activities in collaboration with internal and external stakeholders. This team enhances OGD’s ability to address complex global issues strategically and proactively as a leader in the science and regulation of generic medicines.

PROGRAM MANAGEMENT AND ANALYSIS STAFF - Manages OGD’s administrative operations, budget, and facilities management, including service and support for human resource and personnel operations.

QUALITY MANAGEMENT STAFF - Partners with staff across OGD to provide support in matters related to informatics, project management, training, and process improvement.

Office of Bioequivalence (OB)

Partha Roy, Ph.D., Director, Office of Bioequivalence

Jennifer Miller, Ph.D., Deputy Director, Office of Bioequivalence

OB consists of its own Immediate Office, three Divisions of Bioequivalence, and the Division of Bioequivalence Process Management.

DIVISIONS OF BIOEQUIVALENCE I, II, III (DB I, DB II, DB III) - Assesses pharmacokinetic, pharmacodynamic and in vitro data to ensure therapeutic equivalence. Evaluates formulations for excipient safety, proportionality and qualitative (Q1) and quantitative (Q2) sameness. Addresses scientific and regulatory challenges, product safety, drug product quality and methodologies/approaches for demonstrating bioequivalence by collaborating with various offices within OGD, and throughout CDER and FDA.

DIVISION OF BIOEQUIVALENCE PROCESS MANAGEMENT - Leads and manages all processes associated with bioequivalence review throughout the drug product lifecycle for all Abbreviated New Drug Applications (ANDAs). Coordinates and manages the bioequivalence workload, meeting management, and activities of internal division review teams associated with bioequivalence reviews.

Office of Generic Drug Policy (OGDP)

Kristin Davis, J.D., Director, Office of Generic Drug Policy

Christopher Pruitt, J.D., Deputy Director, Office of Generic Drug Policy

OGDP consists of its own Immediate Office and three Divisions:

DIVISION OF LEGAL AND REGULATORY SUPPORT (DLRS) – Advises OGD regarding generic drug application-specific legal, regulatory, and policy issues and serves as agency experts on Hatch-Waxman and other generic drug regulatory issues. Tracks and helps expedite review of public health priority submissions, including for first generics and drug shortages, to help achieve timely approval of generic drug products. Advises and makes decisions on patent and exclusivity matters for brand and generic drugs and determines timing of generic drug approval.

DIVISION OF ORANGE BOOK PUBLICATION AND REGULATORY ASSESSMENT (DOBPRA) - Publishes and maintains the publication “Approved Drug Products with Therapeutic Equivalence Ratings” (the Orange Book), which provides a range of information on brand and generic drugs, including information regarding market availability, substitutability, drug patents and exclusivity, and ensures timely and accurate information is included in the Orange Book regarding all new drug approvals and therapeutic equivalence evaluations for multi-source products.

DIVISION OF POLICY DEVELOPMENT (DPD) – Provides strategic leadership and direction in the development, clearance, and implementation of regulations, guidances, policies, procedures, and other documents affecting the regulation of generic drug products. Collaborates with all FDA offices supporting the generic drug program to ensure timely implementation and fulfillment of FDA’s commitments pursuant to the Generic Drug User Fee Amendments (GDUFA). Ensures consistency across CDER policies and procedures affecting regulation of generic drug products, including development and implementation of policy solutions to address lifecycle management matters. Provides clarity to internal and external stakeholders on generic drug regulatory policies and procedures, including development and clearance of responses to inquiries from the executive branch, Congress, media, industry, and foreign governments.

Office of Regulatory Operations (ORO)

Edward “Ted” Sherwood, Director, Office of Regulatory Operations

LCDR Malik Imam, Pharm.D., Deputy Director

ORO consists of its own Immediate Office and three divisions:

DIVISION OF PROJECT MANAGEMENT (DPM) – Houses the Regulatory Project Managers (RPMs) who oversee the review of Abbreviated New Drug Applications (ANDAs) to ensure OGD meets GDUFA goal dates. Provides oversight across all review disciplines, by planning, organizing, prioritizing, and assigning ANDA review work. OGD Division of Project Management Contact List

DIVISION OF FILING REVIEW (DFR) - Ensures incoming ANDAs, relevant prior approval supplements (PASs) and amendments meet established standards for filing. Responds to requests from the Federal Trade Commission (FTC).

DIVISION OF LABELING REVIEW (DLR) - Reviews and approves all aspects of labeling associated with ANDA submissions; coordinates and consults with the new drug divisions when necessary, and monitors New Drug Application (NDA) labeling to advise generic drug applicants of correct model labeling.

Office of Research and Standards (ORS)

Rob Lionberger, Ph.D., Director, Office of Research and Standards

Lei Zhang, Ph.D., Deputy Director, Office of Research and Standards

ORS consists of an Immediate Office (IO), and three Divisions:

DIVISION OF THERAPEUTIC PERFORMANCE I (DTP I) – Focuses on complex products, non-oral delivery routes and drug-device combinations. Conducts and translates regulatory science research into product-specific guidances to provide clear pathways and establish standards to ensure therapeutic equivalence of generic versions of complex drug products. Leads the pre-ANDA meeting process to provide scientific advice to potential applicants on the development of complex products. Supports the ANDA assessment process through consults on complex products.

DIVISION OF THERAPEUTIC PERFORMANCE II (DTP II) – Focuses on oral drug products. Leverages expertise in clinical pharmacology, formulation science, bioanalytical methods, and human subject protection to conduct research that ensures therapeutic equivalence of generic versions of oral drug products and provide timely product specific guidance to generic drug developers. Leads the product-specific guidance development process and manages clinical issues related to product-specific guidance development and pre-application scientific advice. Supports the ANDA assessment process through consults on novel approaches to bioequivalence of oral drug products.

DIVISION OF QUANTITATIVE METHODS AND MODELING (DQMM) – Conducts research, develops and implements quantitative pharmacology and physiologically- and mechanistically-based models to ensure therapeutic equivalence and optimize bioequivalence evaluation approaches for generic drugs. Leads the development of novel data analytics approaches (e.g., big data tools) for in vitro, in vivo and post-market ANDA assessment decisions and generic drug program process optimizations. Supports the ANDA assessment process through consults on the use of quantitative methods in ANDA submissions.

Office of Safety and Clinical Evaluation (OSCE)

William Chong, M.D., Director, Office of Safety and Clinical Evaluation

Kimberly Witzmann, M.D., Deputy Director

The Office of Safety and Clinical Evaluation consists of an Immediate Office and three divisions:

DIVISION OF CLINICAL REVIEW (DCR) - Comprised of a multidisciplinary staff, including physicians, pharmacists, pharmacologists, and other regulatory scientists. DCR is responsible for a variety of review work and consultations that address clinical concerns and the safety of generic drug products, throughout the product life cycle.

DIVISION OF CLINICAL SAFETY AND SURVEILLANCE (DCSS) – Consists of a multidisciplinary staff of physicians, pharmacists, epidemiologists, nurses and other scientists who perform and facilitate broad pre-approval and postmarket generic drug safety and surveillance activities for the Office of Generic Drugs.

DIVISION OF PHARMACOLOGY/TOXICOLOGY REVIEW (DPTR) – Assesses the safety of excipients, impurities, and extractable and leachables in generic drug submissions. DPTR primarily reviews Abbreviated New Drug Applications (ANDAs) for generic drugs and referencing Drug Master Files, but also review other types of submissions to support generic drug development, including pre-ANDA submissions, controlled correspondences, Citizen Petitions, and consults for Health Hazard Evaluations.

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