FDA

Companies regulated by the Food and Drug Administration (FDA) know that expertise and practical advice are critical to the bottom line. Goodwin’s experienced FDA practice, a key component of the firm’s Technology & Life Sciences team, provides strategic counseling and skillful advocacy to companies subject to the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, and related federal and state laws. Our practice covers all aspects of clients’ interactions with federal and state regulators who oversee product development, manufacturing, and marketing activities. We are closely involved in our clients’ pre-market strategies and their implementation, including product development, clinical investigations, expedited review and approval pathways, orphan drug and other designations, premarket applications (e.g., NDAs, 505(b)(2)s, ANDAs, BLAs, biosimilars applications, 510(k)s, de novo requests, and PMAs), dispute resolution and appeals, label negotiations, commercial launch preparation, inspection readiness, and assessment of exclusivity protections. On the post-market side, Goodwin’s FDA attorneys have extensive experience advising clients on labeling, advertising and promotion, adverse event reporting, product recalls, good manufacturing practices (GMPs), agency inspections and remediation of inspection findings, responding to agency enforcement actions, and patent term extension. Our practice also focuses extensively on Hatch-Waxman counseling, litigation, and life-cycle management for both brand and generic companies.

Our lawyers have a keen understanding as to how the agency works and how best to leverage regulatory mechanisms and pathways to achieve clients’ business objectives in the fast-paced industries that FDA regulates. Beyond regulatory interactions and submissions, the Goodwin FDA team works closely with client business teams on corporate transactional matters including initial public offerings, mergers and acquisitions, and licensing deals as well as on litigation when it arises. Additionally, our team represents leading industry trade associations and counsels clients on policy and legislative issues before the FDA, the United States Congress and other policymakers, such as preparing comments on proposed FDA guidance documents and regulations and drafting legislative text to amend FDA’s authorities.

Clients Served:

Manufacturers
Researchers & Developers
Marketers
Suppliers
Investigators & Research Institutions
Inventors
Investors
Trade Associations
Distributors
Retailers
Medical Centers & Health Care Providers
Vendors and Independent Contractors
Non-Profit and Patient Advocacy Organizations

The FDA practice at Goodwin also intersects with the Food + Healthy Living practice on regulatory counseling and enforcement matters involving foods, food additives, functional foods, food packaging, dietary supplements, and nutraceuticals.