Brownstein Hyatt Farber Schreck announced that Michael Goodman has joined the firm as a shareholder in its Denver office.
Goodman advises clients on regulatory, transactional and dispute matters before the U.S. Food and Drug Administration and other health authorities. A registered patent agent, he works with startups and multinational life sciences companies on regulatory and compliance matters involving FDA-regulated products.
His practice includes matters involving prescription and over-the-counter drugs, biologics and biosimilars, medical devices, dietary supplements, cosmetics and conventional foods, as well as kashrut-related food manufacturing issues.
“Michael’s arrival materially strengthens our Life Sciences practice and expands our FDA regulatory capabilities,” said Airina Rodrigues, co-chair of Brownstein’s Intellectual Property Department. “He understands the challenges our clients face—from bringing innovative products to market to managing regulatory enforcement risk—and delivers practical, business-oriented guidance.”
Goodman counsels clients on FDA compliance issues including product classification, labeling and advertising, claim substantiation, inspections, enforcement actions and product recalls. His work also includes advising drug, biologic and medical device companies on product development and commercialization matters involving investigational and marketing applications, expedited regulatory pathways and designation programs.
In addition, Goodman advises on supply, manufacturing and distribution agreements and conducts FDA regulatory diligence for mergers and acquisitions, private equity transactions and public company filings.
Before joining Brownstein, Goodman served as in-house regulatory and GMP counsel at a pharmaceutical company, where he advised quality and regulatory teams on inspections, enforcement actions, recalls and health authority responses. Earlier in his career, he practiced at two Am Law 100 firms.
Goodman earned his law degree from the University of Denver Sturm College of Law and bachelor’s and master’s degrees in biotechnology from the University of Wisconsin.