DIA 2016 Annual Meeting

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

On September 29, 2010, FDA issued a final rule amending its regulations governing expedited IND safety reporting requirements that revised the definitions used for reporting and clarified when to submit relevant and useful information in order to reduce the number of uninformative reports distributed by sponsors. An audit of randomly selected expedited safety reports submitted to FDA’s Office of Hematology and Oncology Products (OHOP) in 2015 revealed that the majority of submitted safety reports were uninformative. Submission of uninformative expedited safety reports by commercial sponsors of INDs continues to be a significant problem that can compromise detection of valid safety signals. Representatives from OHOP will present the current state of safety report submissions and efforts to modernize safety reporting.

Learning Objectives

Recognize the current state of safety report submissions to FDA’s Office of Hematology and Oncology Products (OHOP) based on a 2015 audit of safety reports as well as actions that OHOP has taken to guide sponsors to submit informative safety reports; Describe processes and procedures that the pharmaceutical industry has implemented to improve expedited safety reporting practices for hematology and oncology products; Describe OHOP-led initiatives to modernize safety reporting submission.

Chair

Tamy Kim, PharmD

Speaker

FDA Perspective
Suranjan De, MBA, MS

A Large Pharma’s Experience with Implementing the FDA Final Rule on Expedited IND Safety Reporting
Nina Stuccio, DO