November 9-11, 2020 | Virtual Conference


Jane Axelrad, J.D.

Axelrad Solutions LLC

Jane A. Axelrad is a consultant on regulatory policy, oversight, and compliance issues affecting the Food and Drug Administration (FDA).

For almost 25 years, she was the Associate Director for Policy in the Center for Drug Evaluation and Research (CDER) at FDA. In this position, she led multidisciplinary teams of scientists, technical experts and attorneys in addressing complex regulatory policy issues. In addition, from 1995-2012, she created and led the CDER Office of Regulatory Policy, which was responsible for writing regulations and guidance documents for the Center and providing policy advice to the Center Director. She created and chaired the CDER Policy Council, a multi-disciplinary team responsible for overseeing the development of regulatory policy governing human pharmaceuticals, and she was a member of the FDA’s Regulatory Policy Council. She also was a member of the CDER Executive Committee, the governing body of CDER’s 4,000+ staff.

Ms. Axelrad was a member of FDA’s negotiating team for four reauthorizations of the Prescription Drug User Fee Act (PDUFA). In addition, she negotiated with Congress and stakeholders to develop critical pieces of legislation including the Food and Drug Administration Modernization Act of 1997 (FDAMA), the Food and Drug Administration Amendments Act of 2007 (FDAAA), the Food and Drug Administration Safety and Innovation Act (FDASIA) (2012), and the Drug Quality and Security Act (DQSA) (2013). After enactment, Ms. Axelrad led many of the Center’s activities to implement these laws. From 2012-2016, Ms. Axelrad was the Agency lead for the pharmacy compounding initiative where she led the development of numerous regulations and guidance documents to implement the drug compounding provisions of the DQSA. She also oversaw the agency’s compounding inspection and enforcement efforts.

Ms. Axelrad earned a JD from the Columbus School of Law, Catholic University of America, and a BA in Mathematics and Sociology from the University of Michigan.

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