New Animal Drugs for Investigational Use and New Animal Drug Applications

摘要

The Food and Drug Administration (FDA) is announcing its intent to propose revisions to its regulations governing new animal drugs for investigational use and new animal drug applications (NADA's). On October 9, 1996, President Clinton signed into law the Animal Drug Availability Act of 1996 (the ADAA). FDA intends to propose revisions to the investigational new animal drug (INAD) and NADA regulations to implement the ADAA. FDA also intends to propose revisions to the INAD and NADA regulations to fulfill its commitment under the National Performance Review to reinvent the regulation of animal drugs. In the President's National Performance Report, ``Reinventing the Regulation of Animal Drugs,'' May 1996, the President announced FDA's proposal to revise its regulations to create a more efficient process for reviewing and approving new animal drugs (NAD's). FDA's proposal for changes in the process for reviewing and approving animal drugs is intended to minimize the regulatory burden upon industry without compromising FDA's ability to ensure that the animal drugs it approves are safe and effective.