Laura A. Rich

Government Experience

• U.S. Food and Drug Administration
  • Senior policy advisor, Office of Dietary Supplement Programs
  • Senior regulatory counsel, Office of Regulations
  • Director, Regulations and Policy Staff, Office of the Center Director
  • Regulatory counsel, Office of the Center Director
  • Regulatory counsel, Office of Prescription Drug Promotion
• U.S. Securities and Exchange Commission
  • Senior attorney, multiple divisions

Education

• J.D. New York University School of Law 1985
• • Note and comment editor, Journal of International Law and Politics
• B.A. English high honors Douglass College/Rutgers University 1982
• • Phi Beta Kappa
• 2016

Bar Admissions

• District of Columbia
• New York

Professional Memberships and Activities

• American Bar Association

• U.S. Food and Drug Administration
  •  Group Recognition Award, Cesium Chloride Workgroup (for exceptional performance in developing a citizen petition response, public health alert, and warning letters regarding cesium chloride in dietary supplements)
  • Group Recognition Award, Flavors in Tobacco Products Advance Notice Work Group
  • Leveraging/Collaboration Award (for developing and issuing a guidance clarifying the use of the deemed, finished products in tobacco products investigations)
  • Policy Development Award, Early-Phase Clinical Trials Guidance Working Group (for exemplary teamwork in providing the first regulatory guidance on considerations for the design of early-phase clinical trials of cellular and gene therapy products)
  • Policy Development Award, CBER/OCTGT Preclinical Guidance Working Group (for exemplary teamwork in generating the first comprehensive scientific and regulatory guidance on pharmacology/toxicology assessment of investigational cellular and gene therapy products)
  • Biologics Sterility Testing Amendments Group Recognition Award (for superior achievement
    of the agency’s mission through teamwork, partnership, shared responsibility, or fostering
    collaboration and coalition to achieve FDA’s goals)
  • Public Health Achievement Award, Constituent Materials Rule Working Group (for outstanding work in modernizing FDA’s constituent materials regulation to facilitate advances in the development of biological products)
  • Policy Development Award (for exemplary leadership work in the facilitation and completion of time-sensitive policy development projects of pivotal importance for CBER)
  • Policy Development Award, CBER Policy Coordinating Committee (for outstanding commitment, dedication, and excellence in the development of CBER’s and FDA’s policy initiatives)
  • Commissioner’s Special Citation, Bio-identical Hormone Replacement Therapy Working Group
• U.S. Securities and Exchange Commission, Chairman Award for Excellence Community