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

Product Categories:

  • Brand & Generic Prescription Drugs
  • Over-the-Counter Drugs
  • Biologics & Biosimilars
  • Medical Devices
  • Mobile Medical Apps and Software
  • In Vitro Diagnostics and Lab-Developed Tests
  • Foods
  • Dietary Supplements
  • Cosmetics

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.

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Life Sciences

Succeeding in the life sciences industry is as much about strategy and execution as it is about research and development. In this highly competitive business, you need more than the best and brightest ideas – you need a legal and strategic partner that understands the challenges of securing funding, safeguarding intellectual property, establishing partnerships, bringing new products to market, opening up new revenue streams, and protecting existing product lines.

Lawyers in our life sciences practice are deeply experienced in corporate governance, financing and M&A transactions, collaborations and licensing, regulatory matters, and intellectual property law. As part of our interdisciplinary approach, we also collaborate with attorneys in our patent litigation, products liability, employment and tax practices to protect client interests and to advocate on their behalf.

With a full service team of highly experienced lawyers resident in key life sciences hubs, our team helps clients find the strategic paths that foster growth and minimize risk across all phases of the corporate life cycle. Motivated by the knowledge that the work that we do with you is improving people’s lives, we serve as an extension of your team so you can focus on your core business.

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Companies facing products liability and mass tort litigation require experienced counsel with a sophisticated, multi-disciplinary practice. At the same time, the stakes for corporate defendants have grown to “bet the company” magnitude in many instances. Companies in these situations count on Goodwin to ensure their interests are optimally protected.
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Intellectual property assets represent significant value for businesses in the United States. For some clients, these assets represent an entire career or a body of research; for others, they're a 100-year-old trademark, or a newly acquired license. Whether it’s structuring transactions or resolving high-stakes property disputes, we understand the unique needs of each client, and anticipate how those needs will change over time. With superior experience– from scientists who’ve worked in the field, to litigators with International Trade Commission and federal court experience – we’re privileged to represent national and international companies in a broad cross-section of industries.
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Pharmaceutical companies need experienced counsel to protect their regulatory interests. Goodwin’s 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. 

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Related Practices
Life Sciences

Succeeding in the life sciences industry is as much about strategy and execution as it is about research and development. In this highly competitive business, you need more than the best and brightest ideas – you need a legal and strategic partner that understands the challenges of securing funding, safeguarding intellectual property, establishing partnerships, bringing new products to market, opening up new revenue streams, and protecting existing product lines.

Lawyers in our life sciences practice are deeply experienced in corporate governance, financing and M&A transactions, collaborations and licensing, regulatory matters, and intellectual property law. As part of our interdisciplinary approach, we also collaborate with attorneys in our patent litigation, products liability, employment and tax practices to protect client interests and to advocate on their behalf.

With a full service team of highly experienced lawyers resident in key life sciences hubs, our team helps clients find the strategic paths that foster growth and minimize risk across all phases of the corporate life cycle. Motivated by the knowledge that the work that we do with you is improving people’s lives, we serve as an extension of your team so you can focus on your core business.

Read More
Products Liability + Mass Torts
Companies facing products liability and mass tort litigation require experienced counsel with a sophisticated, multi-disciplinary practice. At the same time, the stakes for corporate defendants have grown to “bet the company” magnitude in many instances. Companies in these situations count on Goodwin to ensure their interests are optimally protected.
Read More
Intellectual Property
Intellectual property assets represent significant value for businesses in the United States. For some clients, these assets represent an entire career or a body of research; for others, they're a 100-year-old trademark, or a newly acquired license. Whether it’s structuring transactions or resolving high-stakes property disputes, we understand the unique needs of each client, and anticipate how those needs will change over time. With superior experience– from scientists who’ve worked in the field, to litigators with International Trade Commission and federal court experience – we’re privileged to represent national and international companies in a broad cross-section of industries.
Read More
FDA Litigation

Pharmaceutical companies need experienced counsel to protect their regulatory interests. Goodwin’s 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. 

Read More

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