The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), in collaboration with the Office of the Assistant Secretary for Health, National Institutes of Drug Abuse and the Centers for Disease Control and Prevention, is announcing a scientific workshop to initiate a public discussion about the potential value of making naloxone more widely available outside of conventional medical settings to reduce the incidence of opioid overdose fatalities. Academia, government, industry experts and patient advocates will be assembled to discuss which populations are at-risk for opioid overdose and how public health groups are working together to curb the abuse of opioids. We will also seek to identify potential health concerns, social concerns, legal concerns, regulatory issues and future research needs related to making naloxone more widely available.
April 12, 2012
8:30 a.m. to 5:30 p.m.
10903 New Hampshire Avenue
Bldg. 31 Conference Center
Silver Spring, MD 20993
- Federal Register Notice
- Speakers List
- Purpose Statement, Meeting goals, and Agenda
- Attendee List (PDF - 34KB)
- Transcript: Thursday, April 12, 2012 (PDF - 655KB)
- Post Meeting Summary (PDF - 27KB)
Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.
- Populations at Risk for Opioid Overdose (PDF - 569KB) [ARCHIVED]
Len Paulozzi, MD, MPH
Public Health Interventions to Address Opioid Overdose(PDF - 1.4MB) [ARCHIVED]
Naloxone: Effects and Side Effects(PDF - 5.8MB) [ARCHIVED]
Gregory W. Terman MD, PhD
Naloxone: Overview, Criminal Justice and other Special Settings(PDF - 204KB) [ARCHIVED]
Ingrid Binswanger, MD, MPH, MS
Bystander Overdose Education and Naloxone Distribution in Massachusetts(PDF - 1.8MB) [ARCHIVED]
Alexander Y. Walley, MD, MSc
Role of Naloxone in Opioid Overdose Fatality Prevention, April 12, 2012(PDF - 2MB) [ARCHIVED]
Naloxone for Outpatient Use: Data Required to Support an NDA(PDF - 191KB) [ARCHIVED]
Sharon Hertz, MD
Naloxone Expanded Access: OTC status Considerations for a Nonprescription Drug Development Program(PDF - 151KB) [ARCHIVED]
Andrea Leonard-Segal, MD, MS
Considerations for Development and Marketing of Needleless Naloxone HCI Delivery Systems(PDF - 896KB) [ARCHIVED]
Daniel Wermeling, Pharm.D.
Ethical and Regulatory Considerations in Drug Development for IN Naloxone(PDF - 108KB) [ARCHIVED]
Robert 'Skip' Nelson, MD, PhD
Lessons Learned from Implementation of HPV Vaccine(PDF - 170KB) [ARCHIVED]
Gregory Zimet, PhD