The Food and Drug Administration (FDA) has released new guidelines for companies submitting information electronically related to drug and biologic license applications. This guidance helps ensure that data is submitted in a standardized format, which the FDA uses to plan and conduct inspections of research sites, known as Bioresearch Monitoring (BIMO) inspections. The guidance also clarifies which trials need to include certain information, aiming to enhance the FDA's inspection process for safety and efficacy claims in drug applications. Additionally, the guidance addresses previous technical issues and provides updated instructions for submissions under specific FDA regulations.
Simple Explanation
The FDA made a new rule that tells drug companies how to send their information online in a specific way so that it's easier for them to check if the drugs are safe and work well.