CARLO FELIZARDO is an associate in the Food, Drug, and Medical Device Regulatory group, where he assists clients across various FDA-regulated industries in navigating complex legal and regulatory requirements. Carlo works with clients across the entire product development lifecycle, including clinical development programs, marketing authorization pathways, applications and notifications to FDA, and postmarket compliance matters. He has experience advising clients on a wide variety of topics, including pharmacovigilance, adverse event reporting, studies supporting marketing authorization, controlled substances requirements, product promotion, recalls, and FDA enforcement authorities.
Carlo regularly assists clients in engagement with FDA and other agencies. He helps companies prepare responses to warning letters and information requests, and develop and execute remediation and compliance programs following enforcement action. He also works with clients in drafting comments to agency rulemaking and guidance, preparing for meetings with FDA, and developing other agency correspondence.
Carlo also provides regulatory support on transactional and corporate matters involving companies across the life sciences supply chain, including clinical-stage companies, manufacturers of approved and licensed products, distributors, and pharmacies. He assists with due diligence reviews and drafting transactional documents, licensing documents, vendor agreements, and securities filings.
Prior to joining Sidley, Carlo was an associate at an international law firm, where he focused on providing regulatory advice to pharmaceutical and biotechnology companies.