Mastering Adverse Event Reporting

by Suzanne M. Sensabaugh, President and Principal Consultant of HartmannWillner




For those developing a new biologic or pharmaceutical product, FDA adverse event reporting can be confusing. Requirements for submission to FDA are different for IND sponsors than for BLA and NDA applicants. Adverse event reporting is essential to generate important label precautions for both new and currently existing products.

In this paper, you will learn the important terms used in reporting adverse events to the FDA; differences between reporting requirements for INDs, NDAs, and BLAs; timeframes for reporting and what needs to be reported when; and how FDA documents and stores this information.

Get our expert perspective on submission of these important FDA reports.

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