Purpose of Review <p>The goal of this article is to examine whether the current international and U.S. legal framework adequately governs biomedical and pharmaceutical research and development (R&amp;D) conducted in outer space. Using a hypothetical scenario as a reference point, it assesses how international treaties, customary law, and U.S. statutes apply in practice and where they fall short. The analysis focuses on intellectual property, data integrity and traceability, and regulatory considerations when space-generated payloads and associated data are used for development on Earth, and examines how contracts under the existing framework may help address gaps in these areas as the ISS approaches decommissioning and commercially operated space stations emerge.</p> Recent Findings <p>This is a legal analysis rather than a scientific paper. While international treaties establish broad principles and U.S. law provides more detail, neither is fully suited to the operational realities of biomedical research in orbit, particularly in key areas such as intellectual property, data integrity, and the regulatory treatment of space-generated research upon return to Earth.</p>