Health Subcommittee, Energy and Commerce Committee
Introduced
In Committee
On Floor
Passed Chamber
Enacted
FDA Modernization Act 3.0 This bill requires the Food and Drug Administration (FDA) to establish a process that supports nonclinical testing methods for drug development that do not involve the use of animals. Specifically, the FDA must establish a pathway by which entities may apply to have nonclinical testing methods approved for use in a particular context. Qualifying methods must be intended to replace or reduce animal testing and to either improve the safety and efficacy of nonclinical testing or reduce the time to develop a drug. The FDA must issue its decision within 180 days of receiving an application. The FDA must also prioritize the review of applications for drugs that are developed using an approved nonclinical testing method. The FDA must annually post a report on its website that summarizes the results of the bill's implementation, including the number of applications received, types of methods that were approved, and the estimated number of animals saved as result of these methods.
Administrative law and regulatory proceduresAnimal protection and human-animal relationshipsCongressional oversightDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationFood and Drug Administration (FDA)Government information and archivesInternet, web applications, social mediaPrescription drugs
FDA Modernization Act 3.0
USA118th CongressHR-7248| House
| Updated: 2/9/2024
FDA Modernization Act 3.0 This bill requires the Food and Drug Administration (FDA) to establish a process that supports nonclinical testing methods for drug development that do not involve the use of animals. Specifically, the FDA must establish a pathway by which entities may apply to have nonclinical testing methods approved for use in a particular context. Qualifying methods must be intended to replace or reduce animal testing and to either improve the safety and efficacy of nonclinical testing or reduce the time to develop a drug. The FDA must issue its decision within 180 days of receiving an application. The FDA must also prioritize the review of applications for drugs that are developed using an approved nonclinical testing method. The FDA must annually post a report on its website that summarizes the results of the bill's implementation, including the number of applications received, types of methods that were approved, and the estimated number of animals saved as result of these methods.
Administrative law and regulatory proceduresAnimal protection and human-animal relationshipsCongressional oversightDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationFood and Drug Administration (FDA)Government information and archivesInternet, web applications, social mediaPrescription drugs