Amy Speros focuses her practice 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 has experience advising on regulatory and compliance matters ranging from premarket development and testing to approval, commercialization and promotion issues. She has counseled extensively on regulatory marketing exclusivity strategies, including orphan drug issues, as well as on labeling and post-market safety concerns, including FDA-mandated Risk Evaluation and Mitigation Strategy (REMS) programs. Ms. Speros has also assisted clients with a variety of regulatory enforcement matters, including agency inspections and recalls. In the transactional area, Ms. Speros provides regulatory advice on diligence and disclosure matters for large public offerings, mergers, acquisitions and private transactions. She also routinely advises on corporate contractual matters associated with clinical trial, manufacturing, licensing and marketing issues, among others.
Prior to joining Latham, Ms. Speros was the Executive Editor of the Administrative Law Review and a food and drug law research assistant. Her comment “Over the Counter, Under the Radar: How the Zicam Incident Came About Under FDA’s Historic Homeopathic Exception” was published in the Administrative Law Review at 62 Admin. L. Rev. 487 (2010). Since joining Latham, Ms. Speros has continued to publish thought leadership pieces with new developments and critical analysis in the health and life sciences space. Ms. Speros also serves as a member of Latham’s Global Training and Career Enhancement Committee.