7 minute read | August.19.2026
A new era of nuclear medicine is taking shape.
For decades, radioactive isotopes have given physicians an extraordinary ability to see inside the human body—tracing biological processes, identifying disease, and diagnosing conditions with a precision that other technologies cannot always match. Today, that same fundamental capability is being pushed much further. Scientists are increasingly using radioactive isotopes not just to find disease, but to attack it—pairing radioisotopes with molecules that can seek out specific cells and deliver radiation directly to a tumor or other biological target.
The result is one of the most exciting growth areas in medicine. Existing radiopharmaceuticals have already demonstrated the enormous potential of nuclear medicine, particularly in cancer diagnosis and treatment. But the opportunity ahead is much larger. New isotopes, targeting molecules, production technologies, diagnostics, and therapies are opening potential applications across oncology and other areas of medicine—and attracting pharmaceutical companies, emerging developers, manufacturers, healthcare companies, and investors to a sector that is scaling rapidly.
At the center of all of this innovation is something remarkable: radioactivity has become a precision medical tool.
And that is also what makes this industry different.
Radiopharmaceuticals may be medicines, but they are also radioactive materials. Long before a radiopharmaceutical reaches a patient, radioactive material must be produced, processed, possessed, transferred, transported, manufactured into a drug, distributed through a highly specialized supply chain, administered by appropriately authorized medical professionals, and ultimately managed as radioactive waste. Each step can implicate a nuclear regulatory system that exists alongside, and is fundamentally different from, the regulatory framework governing conventional pharmaceuticals.
As radiopharmaceuticals move from a specialized corner of nuclear medicine toward a much larger therapeutic and diagnostic industry, understanding this nuclear regulatory infrastructure is becoming increasingly important. Below, we focus on the “radio”—and what developers, manufacturers, investors, healthcare companies, and other participants in this rapidly expanding industry need to know.
Radioactive materials used in medicine are subject to a specialized nuclear regulatory framework administered by the U.S. Nuclear Regulatory Commission (NRC) and individual Agreement States, alongside regulation by the U.S. Food and Drug Administration (FDA) and other federal and state authorities.
Companies in this space need to anticipate the requirements governing the possession, use, manufacture, distribution, transportation, import, export, and transfer of radioactive materials and radioactive products, especially with respect to:
For nuclear medicine companies, regulatory strategy is business strategy. Licensing and compliance requirements can determine where isotopes and radiopharmaceuticals can be produced, who can possess and distribute them, how products move through the supply chain, where and by whom they can be administered, and ultimately how quickly and efficiently a business can scale. For companies developing new radiopharmaceuticals, medical isotopes, production technologies, or other nuclear medicine platforms, these considerations can shape fundamental decisions from the earliest stages of development through commercialization and ongoing operations.
Anticipating these requirements and building regulatory strategies early—rather than discovering later that the regulatory framework constrains the product, facility, supply chain, or commercialization model already built—is critical for companies in this space.
A transaction involving a radiopharmaceutical or nuclear medicine business presents an unusual deal risk: a buyer cannot acquire the company without necessarily acquiring the regulatory authority needed to operate it.
Radioactive materials licenses are often essential operating assets. NRC and Agreement State requirements can require regulatory approval or other action before a license is transferred or a change in ownership or control occurs. Nuclear regulators may also require licensees to maintain financial assurance for decommissioning or other regulatory obligations, which can require funding, guarantees, surety arrangements, or other financial mechanisms that need to be addressed as part of the transaction. As a result, acquisitions, investments, joint ventures, financings, restructurings, and other transactions involving licensed businesses can trigger regulatory requirements that must be identified early and incorporated into the transaction structure, financing, and closing timeline.
The issue becomes particularly important for businesses operating across multiple states. A radiopharmaceutical, healthcare, manufacturing, or distribution company may operate under numerous radioactive materials licenses issued by the NRC and different Agreement States. A single transaction can therefore require analysis—and potentially regulatory filings or approvals—across multiple jurisdictions, each with its own regulator, process, and timing.
Key nuclear regulatory considerations throughout the deal lifecycle include:
Identifying these issues early can be critical to closing certainty. A buyer may acquire the facilities, intellectual property, workforce, and commercial relationships of a business, but without the necessary regulatory authority to possess and use radioactive material, or the financial assurance required to support that authority, it may not be able to operate the business it just bought. Nuclear regulatory diligence should therefore be approached as part of understanding the value, operability, and execution risk of the transaction—not simply as a regulatory closing checklist.
The opportunity in radiopharmaceuticals extends well beyond the products available today. New isotopes, targeting technologies, production methods, and therapeutic and diagnostic applications are rapidly expanding what nuclear medicine may be able to do, and the number of patients it may be able to reach.
Realizing that potential, however, requires an infrastructure capable of supporting it. Radiopharmaceuticals depend on a highly specialized ecosystem: isotope production, processing and manufacturing capacity, reliable sources of radioactive material, licensed facilities and personnel, specialized transportation and distribution networks, and healthcare providers authorized and equipped to administer the products. And because radioactive isotopes decay, time itself becomes part of the supply chain—making reliability, proximity, transportation, and coordination particularly important.
As the industry scales, these issues increasingly become strategic business questions. Where should isotopes be produced? How can manufacturers secure reliable supply? Where should production facilities be located? How quickly can a manufacturing and distribution network expand into new jurisdictions? Can a new isotope, production technology, or treatment model fit within existing licensing frameworks—or will it require a new regulatory approach?
The next generation of nuclear medicine will require more than extraordinary science. It will require the nuclear infrastructure, supply chains, regulatory strategies, and capital needed to move that science from the laboratory to patients at scale.
For more information, please contact the authors, Amy Roma, Partner; and Stephanie Fishman, Senior Associate.
The Orrick nuclear team focuses on the “radio” in radiopharmaceuticals, bringing deep nuclear regulatory experience to Orrick’s broader life sciences platform.
We help companies and investors navigate the specialized regulatory framework governing radioactive materials—from licensing new isotopes and radiopharmaceutical platforms and building production and distribution networks to securing approvals for investments and acquisitions involving licensed businesses. Our experience allows us to identify and solve the nuclear regulatory issues that can determine whether a facility, transaction, supply chain, or commercialization strategy works in practice. We help companies move nuclear medicine from innovation to commercialization by aligning the regulatory, infrastructure, supply chain, and transactional strategies needed to reach patients at scale.