FDA Modernization Act 3.0

Bill 119 s 355, also known as the Nonclinical Testing Methods Act, is a proposed piece of legislation that aims to require the Secretary of Health and Human Services, specifically through the Commissioner of Food and Drugs, to publish a final rule regarding nonclinical testing methods.

Nonclinical testing methods are used to assess the safety and efficacy of drugs, medical devices, and other products before they are approved for use in humans. This bill seeks to establish clear guidelines and standards for these testing methods in order to ensure the safety and effectiveness of products being brought to market.

The final rule that would be published as a result of this bill would provide specific requirements and procedures for nonclinical testing methods, including the use of animals in testing, the validation of testing methods, and the reporting of test results. This rule would help to streamline the testing process, improve the accuracy and reliability of test results, and ultimately protect the health and well-being of consumers. Overall, Bill 119 s 355 aims to enhance the regulation of nonclinical testing methods in order to promote public health and safety. It is an important piece of legislation that seeks to ensure that products being brought to market have undergone rigorous testing and meet high standards of safety and efficacy.