CDER各位员工：
2012年9月，随着仿制药用户费修正案（the Generic Drug User Fee Amendments of 2012, GDUFA）获得历史性通过，公众对仿制药空前关注，我宣布将仿制药办公室（Office of Generic Drugs, OGD）升格为一个“超级办公室”— 组织架构中包含其它从属办公室并直接向我报告。该组织将加强OGD的运作，满足不断增长的仿制药审评需求。
今天，我很兴奋地告知大家，OGD重组已获批准。OGD代理主任，医学博士Kathleen "Cook"Uhl将继续履行她的职责，领导我们的仿制药计划，行使我们对GDUFA的绩效职责，增强我们确保及时获得高质量、安全、有效的仿制药的能力。
仿制药占美国处方配药量的84%，对于很多患者和消费者来说意味着获得“负担得起”的治疗药品。他们依靠FDA确保仿制药与其相对应的品牌药在临床上具有相同的作用方式。在充分认识仿制药对公众健康和国民经济的重要性方面，将OGD改造成超级办公室是至关重要和必要的一步。作为超级办公室，OGD将协调、管理简化新药申请（ANDA）的审评流程，为仿制药产品提供安全性、监督、临床以及生物等效性审评，并包含为仿制药制定政策和发展监管科学的新办公室。还将与其它CDER办公室一起整合所有的风险评价与降低策略（REMS）及安全性标签说明问题。
按照GDUFA，FDA承诺实现确定的绩效目标。我很高兴向大家宣布，我们达到或超过了第一年的所有GDUFA目标。例如，生产商付费征收系统全面运转，第一年的生产商付费已征收，我们也已超额完成了第一年的招聘计划。
研究与标准办公室（Office of Research and Standards）：包括治疗效能部门（Division of Therapeutic Performance）和定量方法与建模部门（Division of Quantitative Methods and Modeling）
生物等效性办公室（Office of Bioequivalence）：包括三个生物等效性部门和一个临床审评部门（Division of Clinical Review），临床审评部门包括OGD安监小组（the OGD Safety and Surveillance Team）。
仿制药政策办公室（Office of Generic Drug Policy）：包括法律与规制支持部门（Division of Legal and Regulatory Support）和政策制定部门（Division of Policy Development）。
监管运作办公室（Office of Regulatory Operations）：包括项目管理部门（Division of Project Management）、标签审查部门（Division of Labeling Review）、质量管理体系部门（Division of Quality Management Systems）。
在过渡期间，领导上述办公室的分别为Robert Lionberger博士、John Peters医学博士、Keith Flanagan法学博士、Jason Woo医学博士。过渡小组还包括Cook, Kristin Hornberger（代理资深管理官员）和Mary Dempsey（规制事务副主任）。
为确保OGD员工参与重组并熟知实施计划，OGD过渡小组将召开几次“午餐学习”信息发布会。这些会议将提供一个与OGD职员讨论办公室未来架构和相关职能的机会。
作为药品质量办公室（the Office of Pharmaceutical Quality，OPQ）方案的一部分，建议OPQ包括与产品质量相关的工作组，包括CMC和微生物学审评职能部门，这些原本隶属于OGD，以确保在整个CDER和药品生命周期内标准和作用的有效性和一致性。随着OGD成为超级办公室，OGD下属约200名CMC和微生物学审评员仍归属制药科学办公室（the Office of Pharmaceutical Science），然后在OPQ成立时并入新的OPQ。如果适合，将依据FDA NTEU劳资协定（the FDA NTEU Collective Bargaining Agreement），提前与美国财政部雇员工会（the National Treasury Employees Union, NTEU）审查和商讨这些提议的OPQ变化所带来的影响。
OGD重组是我们所做的不懈努力的一部分，以确保仿制药工业秉持高质量标准，加快患者能够获得安全、有效、高质量的仿制药。这也彰显了我们对保持公众对FDA的信任、不断满足日新月异的美国公众健康需求的承诺。
我想感谢Cook、OGD过渡小组，以及所有努力、辛勤工作使得重组得以最终实现的各位。祝贺这一重要里程碑的实现！
Janet Woodcock
2013年12月 翻译：识林-Kapok 2013-12-28
Janet Woodcock Memorandum to CDER Staff
December 2013
CDER Staff:
In September 2012, with the historic passage of the Generic Drug User Fee Amendments of 2012 (GDUFA) and a heightened public focus on generic drugs, I announced plans to elevate the Office of Generic Drugs (OGD) to a “super office” – an office that houses subordinate offices within its organizational structure and which reports directly to me. This reorganization will strengthen OGD’s operations and allow the office to meet the evolving needs of generic drug review.
Today, I am excited to inform you that the OGD reorganization has been approved. Acting OGD Director Kathleen “Cook” Uhl, M.D. will continue in this role, leading our generic drug program, executing on our GDUFA performance obligations and enhancing our ability to ensure timely access to high-quality, safe, and effective generic drugs.
Generic drugs make up 84 percent of prescriptions filled in the United States and represent affordable access to treatment for many patients and consumers. These individuals depend on FDA to ensure that generic drugs perform clinically in the same way as their brand name counterpart drugs. Transforming OGD into a super office is a critical and necessary step in recognizing the importance of generic drugs to public health and our national economy. As a super office, OGD will coordinate and manage the abbreviated new drug application (ANDA) review process, provide safety, surveillance, clinical, and bioequivalence reviews for generic products, as well as contain new offices to develop policy and regulatory science for generic drugs. It will also integrate all Risk Evaluation and Mitigation Strategy (REMS) and safety labeling issues with other CDER offices.
Under GDUFA, FDA made a commitment to achieve certain performance goals. I am pleased to announce that we met or exceeded all of our Year One GDUFA goals. For example, the user fee collection system is in full operation, first-year user fees have been collected, and we exceeded our first-year hiring goals. Next Steps
An OGD Transition Team is implementing the new office and reporting structure. OGD will have a centralized administrative support function and centralized project management for both review and policy work. OGD will have its own governance structure which means it will set its own policy and strategic agenda, ratify its own budget, resolve any disputes, and perform as an executive team. The approved structure consists of the following:
Office of Research and Standards (includes the Division of Therapeutic Performance and the Division of Quantitative Methods and Modeling)
Office of Bioequivalence (includes three divisions of bioequivalence and a Division of Clinical Review, which includes the OGD Safety and Surveillance Team)
Office of Generic Drug Policy (includes the Division of Legal and Regulatory Support and the Division of Policy Development)
Office of Regulatory Operations (includes a Division of Project Management, a Division of Labeling Review, a Division of Filing Review, and a Division of Quality Management Systems)
The Transition Leads for the above offices are Robert Lionberger, Ph.D., John Peters, M.D., Keith Flanagan, J.D., and Jason Woo, M.D., respectively. The Transition Team also includes Cook, Kristin Hornberger (acting senior management officer) and Mary Dempsey (associate director for regulatory affairs).
To keep OGD staff involved in the reorganization and informed of the implementation plans, the OGD Transition Team will hold several upcoming “lunch and learn” information sessions. These sessions will offer an opportunity to discuss the office’s future structure and its related functions with OGD staff.
As a part of the Office of Pharmaceutical Quality (OPQ) proposal, OPQ is proposed to house the product quality-related groups, including CMC and Microbiology review functions, which had previously been in OGD to ensure efficiency and consistency of standards and actions across the Center and drug product lifecycle. As OGD is now a super office, approximately 200 CMC and Microbiology reviewers in OGD will remain in the Office of Pharmaceutical Science, and then move into the new OPQ when it is established. The impact of these proposed OPQ changes will be reviewed in advance and negotiated, as applicable, with the National Treasury Employees Union (NTEU) in accordance with the FDA NTEU Collective Bargaining Agreement.
The OGD reorganization is a part of our ongoing efforts to ensure that the generic drug industry is held to standards of high quality – and our ongoing efforts to expedite the availability of safe, effective, and high quality generic drugs to patients. It also underscores our commitment to maintaining the public’s confidence in an Agency that continues to meet the ever-changing needs of the American public health.
I want to thank Cook, the OGD Transition Team, and all those individuals who have worked so hard and so diligently to make this reorganization a reality. Congratulations on achieving this important milestone.
Janet Woodcock
