Michael Goodman is a nationally recognized attorney and registered patent agent who advises clients on complex regulatory, transactional, and dispute matters in the FDA-regulated space. With nearly 20 years of combined industry and legal experience, Michael counsels startups and established multinational companies on the best, most efficient routes to bring regulated products to market and stay compliant.

His practice encompasses the full lifecycle of FDA-regulated products, including prescription and OTC drugs, medical devices, dietary supplements, cosmetics, and conventional foods. He is also a recognized expert in advising on kashrut-related food manufacturing issues. Michael regularly assists clients with regulatory strategy, product labeling and advertising review, health authority enforcement actions, and large-scale product recalls.

Before joining OFW, Michael served as in-house regulatory and GMP counsel at one of the world’s largest pharmaceutical companies, where he guided global quality and regulatory teams through inspections, enforcement actions, major recalls, and health authority responses. Earlier in his career, Michael practiced at two Am Law 100 law firms, handling high-stakes FDA regulatory, enforcement, advertising, and product liability matters for major pharmaceutical, medical device, biotech, and dietary supplement companies.

He routinely advises on regulatory strategy, labeling and advertising compliance and claim substantiation, enforcement defense, product recalls, and negotiation of supply, manufacturing, and distribution agreements. Michael also regularly handles FDA regulatory diligence in mergers, acquisitions, private equity transactions, and public company filings.

Representative matters include:

• Leading the FDA regulatory diligence on a $1.25 billion acquisition of a national orthotics and prosthetics company.
• Serving as lead regulatory counsel on a $3.3 billion biosimilar portfolio divestment for a global pharmaceutical company.
• Advising a national wellness company with over 200 locations offering services including cryotherapy, red light therapy, infrared sauna sessions, compression therapy, IV therapy, and intramuscular injections.
• Representing a private equity firm targeting distressed companies for asset acquisitions, primarily in the women’s health sector.
• Guiding a global pharmaceutical company through a consent decree and numerous FDA-regulated companies in responding to FDA Form 483 observations and Warning Letters.
• Defending a national grocery store chain in lawsuits alleging false and misleading advertising.
• Assisting a biopharmaceutical company during one of the largest product recalls in U.S. history.
• Advising countless food and dietary supplement companies on labeling, advertising, and marketing compliance with federal and state regulations.
• Representing a major can manufacturer in a cross-border commercial dispute involving spoiled food products.