Association for Accessible Medicines
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Karen Bengtson is a Supervisory Regulatory Health Project Manager in the Office of Research and Standards (ORS), Office of Generic Drugs (OGD), CDER, FDA. She joined ORS in 2018 and is involved in process development and implementation of the pre-ANDA Program. Prior to joining ORS, Karen worked as a regulatory project manager in the Office of New Drugs and the Office of Surveillance and Epidemiology of CDER. She was in private industry for 14 years and worked for several small biotech companies during that time, before joining the FDA. She received her Bachelor of Arts degree in biological sciences from the University of Baltimore, Baltimore County.