Amy Speros is counsel in the San Diego and Washington, D.C. offices of Latham & Watkins. She advises clients on regulatory, compliance, and transactional matters in industries overseen by the Food and Drug Administration (FDA) and other federal health agencies, including the pharmaceutical, biotechnology, medical device, food, dietary supplement, cosmetic, and tobacco industries.
Ms. Speros assists clients with all aspects of the FDA-regulated product life cycle, including, among others:
- Pre-market development and testing
- FDA product submissions
- Market exclusivity strategies,
including orphan drug issues
- Labeling and post-market safety concerns, including Risk Evaluation and Mitigation Strategy (REMS) programs
- FDA and Federal Trade Commission (FTC) regulation of product marketing and promotion
- FDA and Drug Enforcement Administration (DEA) export and import requirements
- Clinical trial, manufacturing, distribution, and other corporate contracts
- FDA inspections
- Civil and criminal compliance and enforcement
In the transactional area, Ms. Speros provides regulatory advice on diligence and disclosure matters for large public offerings, mergers and acquisitions, and private transactions. She has also been involved extensively in Administrative Procedure Act litigation.
Ms. Speros is a former long-time member of Latham’s Global Training and Career Enhancement (TACE) Committee. As part of her pro bono practice, she has advised non-profits on employment and compliance matters and represented veterans in association with the National Veterans Legal Services Program.