Regulatory Affairs Certification (RAC) Practice Exam

How often should new animal toxicology data be submitted as an amendment after IND submission?

1. Every 15 days

2. Every 30 days

3. Every 60 days

4. Only when requested by FDA

The correct answer is: Every 30 days

New animal toxicology data should be submitted as an amendment after the Investigational New Drug (IND) submission every 30 days. This requirement is in place to ensure that the regulatory authorities, particularly the FDA, are kept informed about any safety concerns that may arise from ongoing toxicology studies in animals during the development of a new drug. The 30-day interval allows for timely updates that can be critical for evaluating the safety of the investigational drug. Submitting data more frequently than this interval, such as every 15 days, could overload the FDA with unnecessary information, while less frequent submissions, such as every 60 days or only upon request, would not provide a robust enough framework for monitoring potential safety issues. Regular updates every 30 days strike a balance between adequate communication and efficient management of resources for both the sponsor and the agency.