Resolves to the species of the first marketing authorization, granted by the US FDA (including its Center for Veterinary Medicine), the European Medicines Agency / European Commission, or another national regulator, under any pathway including conditional or expanded conditional approval, for a drug or biologic whose approved labeling names lifespan extension, healthy lifespan or healthspan extension, or aging itself as the indication (rather than a specific disease). Resolves 'Dogs' if that first authorization is for dogs, 'Humans' if for people, 'Another species' if for any other animal, and 'None before 2035' if no such authorization exists by January 1, 2035. Acceptance of a technical section (RXE, TAS, CMC) alone does not count; the authorization itself does. Background: In dogs, the FDA's expanded conditional approval pathway (GFI #261) accepted in November 2023 that a drug intended to extend lifespan in large dogs (LOY-001) has a reasonable expectation of effectiveness, the first such acceptance for any species, and in January 2026 accepted the target-animal-safety section for LOY-002, a daily pill intended to extend healthy lifespan in senior dogs; the company anticipates the final technical section being reviewed in 2027. In humans, aging is not a recognized indication and no drug has been approved for it; the proposed TAME trial of metformin targets a composite of age-related diseases. Related binary questions: Will the FDA conditionally approve a drug to extend lifespan or healthspan in dogs before January 1, 2028? Will the FDA approve any drug for an aging indication in humans before January 1, 2035? Sources: CVM Guidance for Industry #261 https://dvm360.com/view/fda-determines-drug-for-lifespan-extension-in-large-dogs-to-have-a-reasonable-expectation-of-effectiveness https://loyal.com/posts/loy-002-tas https://doi.org/10.1016/j.cmet.2016.05.011 https://w0lph.github.io/k9/why-dogs.html /w0lph/will-the-fda-conditionally-approve /w0lph/will-the-fda-approve-any-drug-for-a

CVM Guidance for Industry #261

This guidance clarifies the eligibility criteria for conditional approval of new animal drugs intended for certain major uses in major species (expanded conditional approval), and describes the criteria CVM intends to consider when determining expanded conditional approval eligibility.