Considerations Regarding Food and Drug Administration Review and Regulation of Drugs for the Treatment of Amyotrophic Lateral Sclerosis; Public Hearing

The Food and Drug Administration (FDA or the Agency) is announcing a public hearing to obtain input on the Agency’s regulation of drugs for the treatment and/or management of amyotrophic lateral sclerosis (ALS). FDA is holding this public hearing to allow patients, caregivers, advocates, health care providers, academia, industry, and other interested persons to give their perspectives on various aspects of the
development of drugs for the treatment or management of ALS. The input from this public hearing will help inform the work of FDA offices that review applications for drugs for the treatment of ALS.

Date:            February 25, 2013

Time:            9:00 a.m. to 5:00 p.m.

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

• Federal Register Notice
• Agenda (PDF - 60KB)

Webcast of the Meeting

• https://collaboration.fda.gov/als/

• Part 15 Public Meeting: FDA Review and Regulations of Drugs for the Treatment of ALS from 9:00 to 10:10
• Part 15 Public Meeting: FDA Review and Regulations of Drugs for the Treatment of ALS from 10:20 to 11:20
• Part 15 Public Meeting: FDA Review and Regulations of Drugs for the Treatment of ALS from 11:30 to 12:25
• Part 15 Public Meeting: FDA Review and Regulations of Drugs for the Treatment of ALS from 1:15 to 2:15
• Part 15 Public Meeting: FDA Review and Regulations of Drugs for the Treatment of ALS from 2:15 to 3:10
• Part 15 Public Meeting: FDA Review and Regulations of Drugs for the Treatment of ALS from 3:20 to 5:00

General Information

For lodging, transportation, driving directions, parking, and security information is available at: Public Meetings at the FDA White Oak Campus

To make electronic comments to the docket please visit http://www.regulations.gov/

For Further Information, Contact: David Banks, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5365, Silver Spring, MD 20993–0002, 301–796–8459, E-mail: david.banks@fda.hhs.gov, or Steve Morin, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg 32, Rm. 5343, Silver Spring, MD 20993–0002 301–796–0161, E-mail: steve.morin@fda.hhs.gov.