Resolves YES if, before January 1, 2035, the FDA approves (via CDER or CBER, any pathway including accelerated approval) a drug or biologic whose approved labeling names aging, biological aging, lifespan extension, healthspan extension, or the delay of multiple age-related diseases as such (rather than a specific disease) as an indication. Approval for a single age-related disease (for example Alzheimer's disease, osteoarthritis, sarcopenia) does not count. Otherwise NO. Background: No drug has been approved for aging as an indication in humans; aging is not a recognized indication at the FDA, which is why the proposed TAME trial of metformin targets a composite of age-related diseases (Barzilai et al., Cell Metabolism 2016). In dogs, by contrast, the FDA Center for Veterinary Medicine has accepted reasonable-expectation-of-effectiveness and target-animal-safety sections for lifespan-extension drugs under its expanded conditional approval pathway. See the companion question: Will the FDA conditionally approve a drug to extend lifespan or healthspan in dogs before January 1, 2028? Sources: https://doi.org/10.1016/j.cmet.2016.05.011 CVM Guidance for Industry #261 /w0lph/will-the-fda-conditionally-approve https://w0lph.github.io/k9/why-dogs.html

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.