Noah Goldstein

Counsel, Life Sciences Regulatory and Compliance at Porzio Bromberg & Newman

Speaker

Noah Goldstein advises pharmaceutical, biotech, and medical device companies on legal, regulatory, and healthcare compliance matters. As counsel in Porzio, Bromberg & Newman’s Life Sciences Legal, Regulatory, and Compliance Practice Group, he provides tailored guidance to support companies at every stage of the product life cycle, from research and development to launch and commercialization.

Noah advises companies of all sizes, including those in the rare disease space and companies with complex products, such as cell and gene therapies. He provides guidance on applicable laws, regulations, and industry guidelines and codes including fraud and abuse laws, the Federal Food, Drug, and Cosmetic Act, FDA and FTC regulations and guidance, OIG guidance, the PhRMA Code, and the AdvaMed Code.

Noah focuses his practice on matters related to interactions and engagements with healthcare professionals, payors, patients, and advocacy organizations, patient support programs, medical affairs and commercial activities and interactions, advertising and promotion, clinical trials, expanded access programs, conflicts of interest, and related privacy considerations. He also helps companies build, operationalize, and assess their healthcare compliance programs.

Noah reviews internal and external company materials and has regularly served as a legal reviewer on materials review committees. He also reviews and prepares trainings, policies and procedures, and contracts. Additionally, he conducts healthcare compliance assessments, formulating compliance action plans that provide a roadmap for addressing key risks.

Noah leans on his past litigation and in-house healthcare compliance experience to provide business-oriented, practical, and risk-focused advice to help clients navigate their unique needs. He enjoys the collaborative and multidisciplinary nature of his work.