Janet Woodcock, M.D., is Director, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA). Dr. Woodcock joined FDA in 1986, assuming the leadership of CDER in May 1994. Prior to joining CDER, she served as Acting Deputy Center Director of the Center for Biologics Evaluation and Research (1990–1992) and Director of the Office of Therapeutics Research and Review (1992–1994), where she oversaw approval of the first biotechnology-based treatments for multiple sclerosis and cystic fibrosis. From 2004 to 2008, Dr. Woodcock provided support to FDA’s Commissioner, serving as Deputy Commissioner for Operations and Chief Medical Officer. During her tenure at FDA, Dr. Woodcock’s achievements have been substantial. Under her leadership, CDER has streamlined review processes for new and generic drugs while improving standards for quality, safety, and effectiveness. The submission of marketing applications and adverse events reports and the review of submissions in FDA have been transitioned to electronic formats. CDER’s regulatory decision-making processes have also been streamlined, making decisions more open and transparent. CDER’s regulatory procedures, and policies are publicly available―scores of technical guidances describing FDA’s thinking on regulatory standards have been issued. Many CDER process are carried out with an unprecedented degree of participation on the part of consumer and patient representatives. An extensive CDER Web site hosts a myriad of helpful information on drug approvals, safety issues, and other critical information targeting consumers, patients, health care practitioners, regulated industry and other audiences. Highlights of select recent accomplishments include negotiations of the 2012 Generic Drugs User Fee Act, which will speed access to safe and effective generic drugs to the public and reduce costs to industry, and the Prescription Drug User Fee Act (PDUFA V) to support timely evaluation and approval of new drugs. PDUFA V has a particular emphasis on patient focused drug development. In 2011 and 2012, Dr. Woodcock launched multiple efforts to support development of new therapies for rare and neglected diseases and new antibacterial therapies. She oversaw the implementation of innovative policies to foster adaptive trial designs (2010) and trial enrichment strategies (2012) and encourage the qualification of new drug development tools (2010) to help speed drug development and evaluation. Following enactment in March 2010 of the Patient Protection and Affordable Care Act (Affordable Care Act), Dr. Woodcock developed and launched the biosimilars effort to create an abbreviated licensure pathway for biological products, then worked on negotiating the Biosimilar User Fee Act of 2012 (BsUFA) to support approval using this new pathway. Dr. Woodcock continues to lead FDA’s Pharmaceutical Quality for the 21st Century initiative, to modernize pharmaceutical manufacturing, and the Safe Use/Safety First initiatives, which are critical to managing drug safety throughout the drug lifecycle and ensuring frequent and clear communications to the public about the risks and benefits of drugs. As Acting Deputy Commissioner for Operations, in 2004, Dr. Woodcock led the Critical Path Initiative, which continues to encourage and foster the development of new and better tools to support medical product research so that drug, device, and biologics development is more predictable and more informative. As Deputy Commissioner and Chief Medical Officer, Dr. Woodcock launched the Sentinel Initiative with the goal of building a new active surveillance system to augment FDA’s existing adverse events monitoring systems. The resulting Mini-Sentinel pilot program, now used to assess safety signals, can access data on more than 130,000 people. As Director of CDER, Dr. Woodcock maintains contact with a variety of diverse constituencies, including the clinical and scientific communities, members of Congress and the Administration, the national media, patient and consumer advocacy groups, the international drug regulatory community, regulated industry, and representatives of Federal and State agencies. She frequently appears in or is quoted by the national media and has testified repeatedly before Congress. Dr. Woodcock has earned numerous awards, most recently, the Arthritis Foundation’s Floyd B. Odlum Making a Difference Award and the Luminary Award from the Personalized Medicine World Conference. She has been the recipient of the Presidential Rank Meritorious Executive Award and three HHS Secretary’s Distinguished Service Awards among many others. She has authored more than 60 publications. Dr. Woodcock received her M.D. from Northwestern University Medical School in 1977, following an undergraduate degree in chemistry from Bucknell University. She has held teaching appointments at Pennsylvania State University and the University of California at San Francisco. Dr. Woodcock lives in Maryland with her husband and is the mother of two daughters.