Latham’s US Food & Drug Administration (FDA) regulatory team guides the world’s leading medical device, pharmaceutical, and biotechnology companies, from innovative startups to mature public companies, through every step of the FDA-regulated product lifecycle.
We draw on deep government and industry experience to provide seasoned counsel on the most challenging and cutting-edge FDA issues, from global clinical trial and pre-market approval strategies to post-market enforcement actions and recalls. Many on our team have held prominent positions in US government agencies and Congress, and provide insightful counsel and effective advocacy advice on FDA policy, legislative matters, and governmental affairs. We also work closely with deal teams to advise on the regulatory aspects of corporate M&A and capital markets transactions, and with litigation teams to defend and facilitate market access to products, particularly in Administrative Procedures Act litigation.
Our FDA regulatory group has played a central role in nearly every FDA legislative initiative of the past two decades. We routinely advise on legislative strategies, write rule-making comments, participate in hearings and panel meetings, and advocate for clients before senior government officials and members of Congress overseeing the FDA, Drug Enforcement Agency (DEA), and other US federal agencies.
Financial Times recognizes the firm’s strengths across metrics that assess legal industry leadership and strategic growth.
Amy Hargreaves of Latham & Watkins LLP has helped numerous health care companies reach favorable settlements amid False Claims Act qui tam litigation and federal investigations into things like false billings and insurance fraud, earning her a spot among the health care attorneys honored by Law360 Rising Stars.
With a deep understanding of health care laws and regulations, compliance-related matters, and False Claims Act litigation, Amy Hargreaves assists clients in navigating complex enforcement environments.