Brownstein Adds Michael Goodman as Shareholder in Denver

Brownstein Hyatt Farber Schreck is pleased to announce that Michael Goodman has joined the firm as a shareholder in its Denver office, further expanding its capabilities in FDA regulatory and life sciences matters.

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.

“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.”

Across these product categories, Goodman 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, Goodman 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, Goodman practiced at two Am Law 100 firms.

Goodman earned his J.D. from the University of Denver Sturm College of Law and his B.S. and M.S. in biotechnology from the University of Wisconsin.