Sydney Menack

Sydney’s FDA practice includes advising clients on product development and approval strategies, promotional and advertising review, postmarket compliance, and responding to FDA enforcement actions. Sydney works with companies across the life sciences sector, including pharmaceutical, biotechnology, medical device, cosmetics, dietary supplement, and food companies, to address regulatory risks under the Federal Food, Drug, and Cosmetic Act and related laws and counsels clients on compliance with US Drug Enforcement Administration (DEA) regulations. Sydney also has experience counseling clients on FDA and Federal Trade Commission (FTC) consumer protection issues.

In her healthcare practice, Sydney assists providers and healthcare entities ranging from hospitals and academic medical centers, physician practices, pharmacies, vision and dental care providers, and hospice facilities with internal compliance programs, fraud and abuse risk assessments, licensing and accreditation issues, and corporate practice of medicine analyses. Sydney has represented clients in responding to federal and state enforcement actions and FCA investigations, including those involving the US Department of Health and Human Services Office of Inspector General (HHS OIG), where she has guided organizations through the negotiation and implementation of corporate integrity agreements (CIAs).

Sydney earned her J.D. from the University of Maryland Francis King Carey School of Law, during which time she served as the editor-in-chief for the Journal of Health Care Law and Policy.