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Activity Number: 359 - Contributed Poster Presentations: Biopharmacutical Section
Type: Contributed
Date/Time: Tuesday, July 31, 2018 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #330908
Title: Safety Data Presentations in USPIs: Methodological Considerations
Author(s): Adam Boyd* and Michael Pickard
Companies: Array BioPharma Inc and Array BioPharma Inc
Keywords: Package inserts; labels; safety; oncology

In 2011, FDA issued a guidance document addressing the content and format of sections of Labeling for Human Prescription Drug Products, including a recommendation that Adverse Reaction descriptions contain "[a] succinct description of the adverse reaction and outcome (e.g., when the reaction occurs, whether the reaction abates over time despite continued treatment, time to resolution, significant sequelae)."

Describing summaries such as "when the reaction occurs" or "time to resolution" for adverse reactions requires additional specifications. Is it important to describe time to first occurrence, or worst occurrence? Is it important to understand time to resolution of first occurrence, or time until the adverse reaction is no longer ever experienced? The answers to these questions will depend on several factors, but within certain settings (e.g., solid tumor studies with targeted agents), use of consistent methodology across package inserts would enable healthcare providers and patients to make more informed decisions.

We provide a summary of methodology used in approved US oncology drug labels and highlight approaches that could be considered for future oncology labels.

Authors who are presenting talks have a * after their name.

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