FDA Publishes Draft Guidance on Three-Year New Clinical Investigation Exclusivity

The FDA published draft guidance on June 2, 2026 explaining how it interprets three-year new clinical investigation exclusivity under the Hatch-Waxman Act, which grants regulatory protection to drug applications conducting new clinical investigations essential for approval. The guidance clarifies eligibility criteria through a Q&A format but notably omits detailed discussion of exclusivity scope, an area that has frequently been the subject of citizen petitions and litigation.