Director of Special Programs, Office of New Drugs, CDER, FDA
Kevin Bugin works for the FDA in the Office of New Drugs as the Director of Special Programs, leading various internally driven initiatives for the enhancement of the new drugs regulatory program. Prior to joining the FDA, Kevin Bugin worked in both industry and government in multiple...
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Deputy Director for Operations, Office of New Drugs, CDER, FDA
Khushboo Sharma is the OND Deputy Director for Operations in CDER's Office of New Drugs. In this role, Khushboo has oversight of business processes and staff providing key support for regulatory review and oversight of resource capacity planning including staffing for OND. Khushboo...
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Director, Office of New Drugs, CDER, FDA
Peter Stein, M.D., is the Director of CDER’s Office of New Drugs (OND). OND is responsible for the regulatory oversight of investigational studies during drug development and decisions regarding marketing approval for new (innovator or non-generic) drugs, including decisions related...
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Acting Commissioner, FDA, United States
Dr. Janet Woodcock began her long and distinguished FDA career in 1986. In 1994, Dr. Woodcock was named Director of the CDER, overseeing the center’s work that is the world’s gold standard for drug approval and safety. In that position, she has led many of the FDA’s groundbreaking...
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