Seth works with clients to develop and implement premarket strategies and product approvals and handles matters involving postmarket compliance and enforcement defense. His work covers FDA-regulated industries including pharmaceuticals, medical devices, biotechnology, food, dietary supplements, cosmetics, tobacco, and emerging areas such as digital health, cannabidiol, psychedelics, artificial intelligence, and cybersecurity. Seth regularly guides clients through medical device premarket submissions, including Premarket Notifications [510(k)s], Premarket Approvals (PMAs), and Investigational Device Exemptions (IDE), as well as pharmaceutical submissions, such as New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDA), and Investigational New Drug exemptions (INDs). Seth helps clients with business-focused labeling and promotional reviews, including those requiring USDA review; good manufacturing practice (GMP) and quality system compliance; adverse event reporting; and imports. He also supports clients during inspections and audits, manages product recalls, and represents them in enforcement matters involving state regulators, the FDA and U.S. Department of Justice, among other agencies.