FDA conducted a Patient-Focused Drug Development public meeting and scientific workshop on Female Sexual Dysfunction (FSD) on October 27 and October 28.
Day 1 – October 27th Patient-Focused Drug Development Public Meeting
FDA is interested in obtaining patient input on:
1. The impact of the most common form of FSD, female sexual interest/arousal disorder (FSIAD) on daily life
2. Patients’ views on currently available therapies to treat the condition
- Day 1 Meeting Recording Part 1: https://collaboration.fda.gov/p891qyox6wj/
- Day 1 Meeting Recording Part 2 : https://collaboration.fda.gov/p9dt98ftr0o/
Day 2 – October 28th Scientific Workshop
The scientific workshop will include discussion on scientific challenges related to:
1. Diagnosis of the condition for clinical trials and in clinical practice
2. Ensuring valid patient-reported outcome measures for the key efficacy endpoints used in clinical trials
- Day 2 Meeting Recording Part 1 : https://collaboration.fda.gov/p2i1d2i3hpw/
- Day 2 Meeting Recording Part 2 : https://collaboration.fda.gov/p6vrz8wnzm6/
- Day 2 Meeting Recording Part 3 : https://collaboration.fda.gov/p9mbion0nnd/
- Day 2 Meeting Recording Part 4 : https://collaboration.fda.gov/p24kg3zj606/
Date(s) and Time(s)
October 27, 2014 (12:00 p.m. to 5:00 p.m.)
October 28, 2014 (8:00 a.m. to 5:00 p.m.)
FDA White Oak Campus
10903 New Hampshire Avenue
Building 31, Room 1503 B and C
Silver Spring, MD 20993
(Information about arrival to FDA's White Oak campus)
To register for this meeting, visit http://patient-focused-female-sexual-dysfunction.eventbrite.com.
Registration will close on October 20, 2014.
Submitting comments to the public docket:
In addition to providing input at the public meeting, patient stakeholders are invited to provide their perspectives on the discussion questions through the public docket. The docket closes on December 29, 2014.
- FDA is interested in patient responses to the questions listed in the Federal Register Notice
- Visit the following website to submit your comment: Notice of public meeting and workshop; request for comments.
- Day 1 Meeting Agenda (PDF - 209KB)
- Day 2 Meeting Agenda (PDF - 159KB)
- Day 2 Panel Roster (PDF - 36KB)
Webinar: Background on FDA and Patient-Focused Drug Development[ARCHIVED] Flyer for Female Sexual Dysfunction Meetings(PDF - 116KB)
- Federal Register
Day 1 Meeting Slides(PDF - 492KB) Day 2 Meeting Slides(PDF - 1.1MB)
- Day 1 Transcript (PDF - 2.1MB)
- Day 2 Transcript (PDF - 617KB)