Deborah M. Shelton Esq.

Biotechnology Industry Organization
Shelton, Deborah

Deborah M. Shelton serves as in-house counsel to the Biotechnology Industry Organization, managing legal advice and services with respect to legal, policy, and regulatory healthcare matters affecting the biotechnology industry, primarily the regulatory activities of the FDA, CMS, and NIH, and related legislative activities, and serves as a member of the advisory board of Law's Pharmaceutical Law & Industry Report.

Ms. Shelton was previously lead U.S. Counsel to Amgen's Global Biosimilars Legislative and Regulatory Policy and State Government Affairs Team, where she provided guidance on legal, legislative, and regulatory issues related to biosimilars and other biopharmaceuticals.

Prior to joining Amgen, she counseled clients in U.S Food and Drug Administration (FDA), Drug Enforcement Administration (DEA) and administrative law as a Partner with the law firm Sheppard Mullin. A significant part of her law practice focused on providing legal and strategic advice to pharmaceutical companies on Hatch-Waxman issues, and market exclusivities such as new chemical entity, orphan drug, and pediatric. Her work for manufacturers of drugs, biological products, and medical devices ranged from the investigational and approval stages through regulatory compliance and post-marketing requirements. She also guided clients through DEA regulation of controlled substances and precursor chemicals.

She earned her B.S. and J.D. from the University of Maryland.

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