FDA Guidelines on Safety Reporting Requirements for IND, BA and BE

FDA Guidelines on Safety Reporting Requirements for IND, BA and BE

In the FDA’s guidance document “Safety Reporting Requirements for INDs and BA/BE Studies,” the FDA outlines the importance of identifying and characterizing adverse events that arise during the course of clinical trials. Importantly, the FDA outlines the types of events that MUST be reported to the FDA in the form of IND Safety Reports. Describe these events and explain how and when these types of events must be reported to the FDA. How are they reported?

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