Laura A. Rich
Counsel
Laura's practice includes overall regulatory strategy and support, including for new dietary ingredient notifications (NDIN). Laura also focuses on government investigations, FDA enforcement actions, internal compliance, and other regulatory matters in the food and drug industry.
Laura also served as a senior attorney at the U. S. Securities and Exchange Commission, where she worked to resolve, plan, and execute investigations and inspections of regulated entities.
Related Practices
Experience
Experience
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
Insights
Insights
Credentials
Credentials
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
Recognition
Recognition
- 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