Creating an Alternative Approval Pathway for Certain Drugs Intended to Address Unmet Medical Need; Public Hearing

The Food and Drug Administration (FDA) is announcing a public hearing to obtain input on a potential new pathway to expedite the development of drugs, including biological products, for serious or life-threatening conditions that would address an unmet medical need. The drug’s safety and effectiveness would be studied in a smaller subpopulation of patients with more serious manifestations of a condition. Such a pathway could involve smaller and more rapid clinical trials than would occur if the drug were studied in a broader group of patients with a wide range of clinical manifestations. The labeling of drugs approved using this pathway would make clear that the drug is narrowly indicated for use in limited, well-defined subpopulations in which the drug’s benefits have been shown to outweigh its risks. The purpose of the public hearing is to obtain information and comments from the public on the need for and feasibility of this pathway and its potential advantages and disadvantages.


Date:            February 4, 2013 from 9:00 a.m. to 5:00 p.m.

Location:     FDA White Oak Campus
                      10903 New Hampshire Avenue, Bldg. 31 Rm. 1503
                      Silver Spring, Maryland 20993

Transcripts of the public hearing and all of the Presentations will be available for review at the Division of Dockets Management and on the Internet at: http://www.regulations.gov approximately 30 days after the public hearing.

Visitor Information

All meeting attendees must enter through Building 1 on the FDA White Oak Campus. Parking is available in the Southeast surface lot and a shuttle bus will be available to bring attendees from the lot to Building 1. Please see Directions/Transportation/Parking/Hotels for the FDA White Oak Campus (PDF - 115KB) for directions and further details about transportation and lodging. Map of White Oak Visitor Parking (PDF - 105KB)

Attendance and Registration to Speak

The FDA Conference Center at the White Oak location is a federal facility with limited seating. Attendance is free and will be on a first-come, first-serve basis.

Attendees, including those not presenting, need to register for the public hearing. If you wish to attend or make an oral presentation during the hearing, you must register by submitting a written request to ExpeditedPathwayPublicMtg@fda.hhs.gov on or before Januray 22, 2013, and provide complete contact information, including name, title, and affiliation, address, e-mail, and phone number. Those without email access may register by contacting Tomeka Arnett, Center for Drug Evaluation and Research, Food and Drug Administration at 301-796-2500. FDA will do its best to accommodate requests to speak and will determine the amount of time allotted to each presenter and the approximate time that each oral presentation is scheduled to begin.

If you need special accommodations because of disability, please contact Jonas Santiago, Center for Drug Evaluation and Research, Food and Drug Administration, phone (301)796-5346, e-mail ExpeditedPathwayPublicMtg@fda.hhs.gov at least 7 days before the meeting.

Webcast of the Meeting

The webcast can be accessed via the following links:

For those unable to attend in person, the meeting will also be shown via webcast. Watch the webcast on February 4th from 9:00 am to 5:00 pm. Requirements and instructions for accessing the webcast are below. Please be sure to download the most up-to-date version of Flash Player.

You may access the webcast via this link: https://collaboration.fda.gov/altapprovefeb2013/.

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