FDA Modernization Act 3.0

HR 7248, the FDA Modernization Act 3.0, creates a new FDA process to qualify alternative nonclinical testing methods that can replace or reduce animal testing in drug development. Drug developers can request qualification for methods that improve safety/efficacy predictivity or shorten development time, with the FDA required to review requests within 180 days. If qualified, these methods allow expedited FDA review of drug applications and enable referencing the qualified method in submissions. The bill mandates annual reports tracking qualified methods, animal use reduction, and application approvals, with transparency requirements for Congress. This directly affects pharmaceutical companies and biotech firms developing new drugs.