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. For early and late-stage drug and biologic developers, learn more about our range of pre-market expertise here. 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. For medical device manufacturers across both hardware and software technologies, learn more about our range of regulatory counseling here. Given the breadth of clinical-stage companies that the Goodwin FDA team advises, our regulatory attorneys together with our commercial contracting, products liability and insurance attorneys play an integral role in counseling clinical-stage companies on matters related to the conduct of clinical trials. Learn more about our clinical trials service offering here. Our practice also focuses extensively on Hatch-Waxman counseling, litigation, and life-cycle management for both brand and generic companies.
Our experienced FDA 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, Goodwin’s FDA lawyers work 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. And with the breakneck pace of technology disrupting industries around the world, we partner with clients to embrace the promise and potential of innovation to make a lasting impact. 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.
- Researchers & Developers
- Investigators & Research Institutions
- Trade Associations
- Medical Centers & Health Care Providers
- Vendors and Independent Contractors
- Non-Profit and Patient Advocacy Organizations
- Brand & Generic Prescription Drugs
- Over-the-Counter Drugs
- Biologics & Biosimilars
- Medical Devices
- Mobile Medical Apps and Software
- In Vitro Diagnostics and Lab-Developed Tests
- Dietary Supplements
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.