Category: Regulatory Safety reporting requirements

IND Safety Reporting Summary: IND application sponsors are required to notify FDA in a written safety report of: any adverse experience associated with the use of the drug that is both serious and unexpected or any findings from tests in laboratory animals that suggest a significant risk for human subjects …

Post Marketing Safety Reports: The manufacturers must submit post-marketed safety reports to the FDA in electronic format for their medicinal products and vaccines. Types of Adverse event experiences: Serious and unexpected adverse experiences from all sources, whether domestic or foreign, must be submitted to the FDA. Possible sources include, for …