Michael R. Goodman is an attorney and registered patent agent who advises clients on FDA regulatory compliance and litigation needs in the food and beverage, medical device, pharmaceutical, biotechnology, and dietary supplement industries. He has deep experience with both startups and large multinational companies. Before practicing law, Michael spent almost a decade in industry and brings his experience to every client.
Michael has worked with countless startup companies in the FDA space, helping them navigate the daunting and complex regulatory challenges. He takes pride in preparing, reviewing, and negotiating—in most cases—his young clients’ first supply and distribution, manufacturing, and advertising agreements. In particular, his medical device clients regularly use him to classify their new innovations and advise as to efficient and cost-conscious ways to meet the FDA’s requirements.
Michael also works with some of the largest FDA-regulated manufacturers and distributors in the world. Michael leverages his industry experiences in building supply-chain management systems; negotiating complex, multinational supply and distribution, and manufacturing agreements; advising his clients on regulatory inspections and responses; and large-scale recalls.
The priorities of every company are different and there is no one-size-fits-all model to legal advice. Michael is unique from other FDA attorneys in that Michael leverages his past industry experiences to tailor his advice to the needs of each of his clients. He began his career as an organic chemist at a large contract manufacturer. There, he focused on development and scale-up of small molecular entities administered in clinical trial test subjects. Then he moved into a position in regulatory affairs and quality assurance at a large biopharmaceutical company. From there, he pivoted into consulting large and small medical device, pharmaceutical, biotechnology, and dietary supplement companies on FDA regulatory and quality requirements. While in industry, he helped plan new manufacturing facilities, consulted on process improvements, and represented companies through a multitude of regulatory audits.
Michael’s practice is also unique in that he also has deep experience in a wide range of litigation matters in the FDA-space. Though each client receives tailored advice that accounts for their nuanced needs, all of Michael’s clients are advised on risks of downstream litigation. Yet if litigation is inevitable, Michael is prepared to vigorously defend his clients.
- Product classification, labeling and advertising
- Manufacturing, distribution and supply agreements
- Counseling companies regarding compliance with Good Manufacturing Practices (GMPs), including the implementation of SOPs and other testing requirements
- Assisting companies to address advertising issues, including investigations initiated by the FTC, NAD and ERSP