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 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. 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.
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.
Pharmaceutical companies need experienced counsel to protect their regulatory interests. Goodwin’s Administrative Law and FDA Litigation practice provides counsel, representation and strategic advice that covers all aspects of our clients’ interactions with the Food and Drug Administration. Our lawyers regularly advise clients on regulatory issues, engage with the FDA and other federal and state agencies through Citizen Petitions, comments, meetings and other petitioning, and represent drug manufacturers in Administrative Procedure Act challenges.
Succeeding in the life sciences industry is as much about strategy and execution as it is about research and development. And with the breakneck pace of technology disrupting industries on a global scale, Goodwin’s depth of experience not only in the life sciences space, but also in collaboration with our technology, healthcare, real estate and private equity lawyers, makes our team exceptionally suited to address whatever the future brings. We partner with clients to embrace the promise and potential of innovation to make a profound and lasting impact.
Goodwin’s fully integrated, globally recognized destination life sciences practice is dedicated to serving the needs of innovators and investors working collaboratively to improve patients' lives. Our team of more than 150 lawyers is devoted to life sciences companies across the entire company lifecycle, and team members are strategically located across the major life sciences hubs in the U.S., Europe and Asia.
Pharmaceutical companies need experienced counsel to protect their regulatory interests. Goodwin’s Administrative Law and FDA Litigation practice provides counsel, representation and strategic advice that covers all aspects of our clients’ interactions with the Food and Drug Administration. Our lawyers regularly advise clients on regulatory issues, engage with the FDA and other federal and state agencies through Citizen Petitions, comments, meetings and other petitioning, and represent drug manufacturers in Administrative Procedure Act challenges.
Succeeding in the life sciences industry is as much about strategy and execution as it is about research and development. And with the breakneck pace of technology disrupting industries on a global scale, Goodwin’s depth of experience not only in the life sciences space, but also in collaboration with our technology, healthcare, real estate and private equity lawyers, makes our team exceptionally suited to address whatever the future brings. We partner with clients to embrace the promise and potential of innovation to make a profound and lasting impact.
Goodwin’s fully integrated, globally recognized destination life sciences practice is dedicated to serving the needs of innovators and investors working collaboratively to improve patients' lives. Our team of more than 150 lawyers is devoted to life sciences companies across the entire company lifecycle, and team members are strategically located across the major life sciences hubs in the U.S., Europe and Asia.
