Andrew Leboeuf

Experience

1. Associate Director for Policy

   FDA

   Apr 2021 — Present

   Independently provides significant regulatory, scientific, and technical expertise and strategic counsel on the development and implementation of unique, complex, and precedent-setting policies impacting the review and approval of drugs and biological products. • Serves as Subject Matter Expert on Emergency Use Authorizations (EUA) covering therapeutics for the Coronavirus Disease 2019 (COVID-19) public health emergency; provides substantial regulatory and policy support to OND’s clinical offices on the review, issuance, revision, and revocation of EUAs. • Represents OND in meetings with senior Center, Agency, and United States (U.S.) Department of Health and Human Services officials as well as members of Congress and/or their staff, health care industry representatives, and other stakeholders on the U.S. Government’s response to the COVID-19 public health emergency. • Advises on new or revised strategic regulatory policy initiatives of critical interest to OND including, but not limited to policies on the review and approval of Part 3 combination products (e.g, drug-device combination products); the regulatory framework for digital health technologies intended for use with drugs or biological products; and the implementation of Risk Evaluation and Mitigation Strategies (REMS) and Safety Labeling Changes (SLC) authorities provided for under the Federal Food, Drug & Cosmetic Act (FD & C Act). • Served as Acting Associate Director for Policy from April, 2021 until September, 2022.

Education

• The John Marshall Law School

  Juris Doctor

  2006 — 2009

• Rosalind Franklin University

  Masters of Science, Applied Physiology

  2004 — 2006

• Loyola University Chicago

  Bachelor of Science, Biology

  2000 — 2004