Background
FDA regulatory counsel for life sciences and biologics companies. Advises on regulatory strategy, expedited programs, and compliance and enforcement across the full product lifecycle. Brings in-house experience to complex transactions.
Michael Goodman advises clients on complex regulatory, transactional, and dispute matters before FDA and other health authorities. With nearly 20 years of industry and legal experience and as a registered patent agent, he guides startups and multinational corporations in the life sciences sector on the best strategies to bring regulated products to market and remain compliant.
His practice encompasses the full lifecycle of FDA-regulated products, including prescription and OTC drugs, biologics and biosimilars, medical devices, dietary supplements, cosmetics and conventional foods, as well as kashrut-related food manufacturing issues. Across these product categories, Michael advises clients on core FDA compliance matters including product classification, labeling and advertising, claim substantiation, inspections, enforcement actions and product recalls. For drug, biologic and medical device clients, he counsels on product development and commercialization, including INDs, IDEs, NDAs, BLAs, 510(k) submissions, De Novo requests and PMAs, as well as expedited pathways such as breakthrough therapy, breakthrough device, regenerative medicine advanced therapy and orphan drug designation programs. He also advises on the negotiation of supply, manufacturing and distribution agreements and regularly conducts FDA regulatory diligence for mergers, acquisitions, private equity transactions and public company filings.
Previously, Michael served as in-house regulatory and GMP counsel at a leading pharmaceutical company, guiding global quality and regulatory teams through inspections, enforcement actions, major recalls and health authority responses. Earlier in his legal career, Michael practiced at two Am Law 100 firms.
Representative Matters
- 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.
News
News
Credentials
EDUCATION
2016, J.D., University of Denver Sturm College of Law
2011, M.S., Biotechnology, University of Wisconsin
2006, B.S., Biochemistry, University of Wisconsin
ADMISSIONS
Colorado
District of Columbia
