KELLY CHO advises clients on a wide range of FDA regulatory and compliance matters affecting drugs, biological products, medical devices, animal health products, cosmetics, food, and other products regulated by the agency.
Kelly is passionate about novel cutting-edge technologies and draws upon her background in molecular and cellular biology to advise on scientifically complex issues and products. Kelly regularly assists clients on questions that may arise throughout a product’s lifecycle with respect to marketing authorization pathways, clinical trials, expedited programs and designations, FDA’s application review and approval process, regulatory exclusivities, adverse event reporting, and other postmarket compliance issues. Kelly also advises on questions related to advertisement and promotion, priority review vouchers, registration and listing requirements, the Drug Supply Chain Security Act (DSCSA), and import and export requirements.
Kelly also counsels clients on their FDA engagement strategies, including contentious proceedings against the agency. Kelly regularly helps draft clients’ submissions to FDA and prepare for regulatory meetings, advisory committee meetings, and other types of interactions. Kelly also assists clients with strengthening their internal procedures to reduce compliance risks and provides regulatory diligence to support transactions and securities filings in the life sciences industry.
Prior to joining Sidley, Kelly worked at another international law firm where she represented pharmaceutical and medical device manufacturers in Hatch-Waxman patent litigations and product liability disputes.