Food and Drug Administration (FDA)
Jackson Walker has comprehensive experience counseling entities regulated by the U.S. Food and Drug Administration (FDA). The firm’s combined capabilities across Healthcare, Corporate & Securities, Government Relations and Public Policy, Intellectual Property, and Trial & Appellate Litigation provide FDA-regulated entities with a full-service legal team capable of supporting all aspects of the business cycle.
We counsel entities—from large, diversified companies to entrepreneurs and investors—in key areas regulated by FDA, including:
- Animal and veterinary products, including animal drugs and drug compounding;
- Clinical trials;
- Cosmetics;
- Food (both human and animal), beverage, and dietary supplements;
- Human pharmaceuticals and biotechnology products, spanning all therapeutic areas;
- Medical devices (especially software-as-a-medical-device) and diagnostics; and
- Vaccines
We focus on services keyed to both enterprise- and product-level compliance, as well as day-to-day business operations, including:
- Regulatory strategy and product lifecycle management;
- Contract drafting and negotiation (e.g., clinical trial agreements, joint ventures);
- Compliance and risk management operations;
- Due diligence support for M&A activities;
- FDA enforcement actions (e.g., 483s, untitled letters, warning letters) and related internal investigations;
- Marketing and promotional activities for regulated products (e.g., claims, labeling);
- Public policy and advocacy to support industry priorities
We are uniquely positioned to support global operations for FDA-regulated entities, including both ex-U.S. companies entering the U.S. market for the first time and U.S. companies entering new markets abroad. We have experience supporting FDA-equivalent regulatory operations in Canada, across the Asia-Pacific region, the European Union and United Kingdom, Latin America, and the Middle East. In particular, we provide regulatory and transactional support for managing the vendor ecosystem required for global growth (e.g., importers, distributors, manufacturers).
- Counseled health system on FDA compliance and enforcement matters relating to its in-house medical software development program (US FDA law / software)
- Counseled medical publisher on FDA compliance and enforcement matters relating to its software products (US FDA law / software)
- Counseled cosmetics company on its contractual agreements for formulation development and product manufacturing (US FDA law / cosmetics)
- Counseled food company on FDA compliance matters regarding product marking and promotion (US FDA law / human food)
- Counseled medical company specializing in fertility on its acquisition of a fertility clinic and laboratory (US FDA law / human cells, tissue, and cellular and tissue-based products)
- Counseled global packaging company on FDA compliance and enforcement risks associated with a proposed acquisition (US FDA law / enforcement)
- Counseled global medical device company specializing in proton therapy systems on FDA compliance matters relating to a proposed M&A transaction (US FDA law / device)
- Counseled physician-investigator on a clinical trial agreement with a global pharmaceutical company (US FDA law / clinical trials)
- Counseled a drone delivery company on FDA compliance matters relating to over-the-counter drugs (US FDA law / OTC drugs)
- Counseled global medical device company specializing in neonatal and perinatal products on its acquisition of another global medical device company (US FDA law / device, US law / FCPA, EU law / device, EU law / GDPR)
- Counseled warehousing and fulfillment company on animal food compliance matters (US FDA law / animal food)
- Counseled veterinary telemedicine company on FDA compliance matters relating to extra-label drug use in animals (US FDA law / animal drug)
- Counseled warehousing and fulfillment company on animal drug compliance matters (US FDA law / animal drug)
- Counseled veterinary pharmacy company on FDA compliance matters relating to animal drug compounding (US FDA law / animal drug compounding)
April 25, 2023
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Key Considerations for Clinical Investigators When Negotiating Clinical Trial Agreements
By Nicholas J. Diamond and Taylor McDowell
Clinical trials are an essential component of the research architecture for developing new drugs and devices. Research institutions and their clinical investigators play an important role in supporting drug and device manufacturers—the clinical trial sponsors—in developing the data and evidence required to support regulatory submissions.
September 30, 2022
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How Cos. Can Adapt to Global AI Regulation Trends | Law360
By Nicholas Diamond | Regulators globally are exploring new regulatory regimes for artificial intelligence with activities continuing to ramp up since last year.
July 27, 2022
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FDA Releases Draft Guidance on Remote Regulatory Assessments
By Nicholas J. Diamond
The U.S. Food and Drug Administration has indicated in its draft guidance that it intends to continue to use remote tools to support oversight activities, including a hybrid approach for inspections that combines both onsite and remote modalities, beyond the COVID-19 pandemic.
- Regulatory strategy and product lifecycle management
- Contract drafting and negotiation
- Compliance and risk management operations
- Due diligence support for M&A activities
- FDA enforcement actions and related internal investigations
- Marketing and promotional activities for regulated products
- Public policy and advocacy to support industry priorities
