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Posted 01 July 2015 | By Alexander Gaffney, RAC,
Since the passage of the Food and Drug Administration Safety and Innovation Act (FDASIA) in 2012, the US Food and Drug Administration (FDA) has been publicly meeting with patients who suffer from debilitating conditions without adequate treatment options in the hopes of better understanding their wants and needs in the drug development process.
Those meetings have raised novel questions for regulators, who for the first time are asking patients and patient groups to explain how diseases affect their daily lives, and what roles treatments do—and do not—play in helping them to manage their diseases and symptoms.
Last Updated: 1 July 2015
Embedded tables may overflow page—please scroll if necessary.
To date, FDA has announced 15 patient-focused drug development meetings:
For information on those meetings, including meeting transcripts, please see FDA's patient-focused drug development webpage.
FDA has also announced one other disease categories it plans to hold meetings on prior to 2016:
In addition, FDA has already begun planning its next batch of patient-focused drug development meetings. In July 2015, it released a list of eight diseases and conditions it plans to hold meetings for under the PFDD program between FY 2016-2017:
Other diseases and conditions are likely to be considered under the next reauthorization of PDUFA in FY 2018-2022.
An at-a-glance listing of FDA's most common questions for patients may be found below. (Table may overflow page—scroll if necessary)
FDA's Most Commonly Asked Questions for Patients
A complete listing of all questions asked by FDA of each respect disease may be found below. (Table may overflow page—scroll if necessary)
How do your symptoms and their negative impacts affect your daily life on the worst days?
Tags: Patients, Patient-Focused Drug Development, FDASIA, View of Patients, PFDD
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