Arlene Brens Figueroa
Regulatory Counsel @FDA
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WORK HISTORY
Regulatory Counsel @FDA
Silver Spring, MD, US
Provide legal guidance to FDA reviewers on complex concepts, risks, and regulatory barriers for drug approvals.• Lead efforts to approve first generic products by responding to citizen petitions and coordinating with multiple FDA offices.• Draft responses to citizen petitions and formal dispute resolution requests to aid in approval and submission of generics.• Research a broad range of issues concerning Hatch-Waxman Amendments to the FD & C Act, pertinent regulations, and policy documents to provide guidance to internal clients.• Presented on Submission of Suitability Petitions and best practices at the Center for Drug Evaluation and Research (CDER) Small Business and Industry Assistance (SBIA) event, April 2024.
EDUCATION
Indiana University Maurer School of Law
Juris Doctor, cum laude
Syracuse University
Bachelor of Arts - BA, magna cum laude
SKILLS
ABOUT ARLENE BRENS FIGUEROA
As a Regulatory Counsel at the FDA, I leverage my legal expertise to ensure compliance…
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