Amends the Federal Food, Drug, and Cosmetic Act to speed generic drugs to market by changing how citizen petitions and related lawsuits are handled. Petitioners must submit and describe their full legal and factual arguments before suing; the agency may issue guidance and consider specified factors when reviewing petitions that appear aimed at delaying approvals; and courts are directed to dismiss lawsuits that don’t follow the new petition and timing rules.

The change is procedural and targets pre-litigation steps that can delay generic-drug approvals. It shifts the timing and exhaustion requirements for challengers, increases FDA authority to address delay tactics, and gives courts a clear basis to reject noncompliant lawsuits — all intended to reduce strategic delays and improve patient access to lower-cost generics.