Overview
Jennifer Bonanno advises clients on US and global regulatory compliance matters involving food-contact materials, processing aids for use with food and alcoholic beverages, medical devices, and drugs. Drawing on her scientific background in chemistry, years in private practice, and prior experience as in-house counsel, Jennifer provides practical, business-focused guidance to help clients navigate complex domestic and international regulatory frameworks, including in the EU, Canada, Japan, China, MERCOSUR, and Australia.
Jennifer regularly assists clients with US Food and Drug Administration (FDA) submissions, including food contact notifications (FCNs), threshold of regulation (TOR) requests, premarket notifications for medical devices (510(k) notices), and investigational new drug applications (NDAs). She also prepares legal opinion letters addressing the regulatory status of food additives, food-contact materials, drug packaging, and modified medical devices marketed under a 510(k) notification.
Earlier in her career, Jennifer served as general counsel for a semiconductor manufacturer and as FDA Counsel and Director of Regulatory Compliance for a biotech pharmaceutical company. She also dedicated several years to volunteer work as a disability advocate.
- District of Columbia
- Pennsylvania
- J.D., American University, Washington College of Law, 1994, cum laude
- B.A., Bowdoin College, 1990, Chemistry, Physics
Representative Matters
*Includes matters handled before joining Steptoe.
- Worked with clients in preparing submissions to FDA to obtain regulatory clearance for substances used in food-contact materials and food processing equipment
- Assisted companies with obtaining FDA No Objection Letters (NoLs) for recycled plastics
- Provided clients with training courses on the FDA regulation of food-contact paper and paperboard
- Establish compliance of wine processing aids under US Alcohol Tobacco Tax and Trade Bureau (TTB) and related FDA requirements
- Prepared premarket notifications (501(k) notification) and assisted clients with the preparation of premarket approval applications (PMAs) for Class I, II, and III medical devices for submission to FDA
- Drafted a request for scientific advice to the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) and successfully conducted a meeting with MHRA to establish a regulatory track for a new drug product in the EU
- Drafted Investigational New Drug (IND) Applications for submission to FDA
- Advised clients on good manufacturing practice (GMP) excursion issues in the food packaging and pharmaceutical industries