The Food and Drug Administration (FDA) is announcing a public workshop regarding anti-infective drug development for neonates and young infants. FDA is interested in discussing the scientific challenges pertaining to development of anti-infective products for neonates and young infants. This public workshop is intended to provide information for and gain perspective from health care providers, other U.S. Government Agencies, public health organizations, academic experts, and industry on various aspects of drug development for new and currently marketed anti-infective drugs for neonates and young infants. The input from this public workshop will also help in developing topics for future discussion.
September 15, 2016
8:30 a.m. to 4:30 p.m.
The public workshop will be held at Sheraton Silver Spring Hotel, 8777 Georgia Ave., Silver Spring, MD 20910. The hotel’s phone number is 301-589-0800.
- Agenda â Facilitating Anti-infective Drug Development for Neonates and Young Infants
- Transcript: Anti-Infective Drug Development in Neonates
- Speakers and Panelists
- Facilitating Anti-infective Drug Development for Neonates and Young Infants, 9/15/2016
- Hope - Use of In Vivo and In Vitro Models to Guide Dose Selection for Neonatal Infections
- Kovanda - Adequate and Well-Controlled Trials in Neonates: Lessons Learned from Neonatal Candidiasis Program
- Noel - Obtaining Clinical Safety and Efficacy Data in Neonatal Infections
- Rubino - Using Pharmacometrics to Facilitate the Design and Analysis of Anti-Infective Drug Studies Neonates
- Smith - The Role of Clinical Trial Networks in Neonatal Studies
- Smith - Establishing Efficacy in Neonates
- Turner - Master Protocols in Neonatal Infections: Pharmacokinetic, Safety and Outcome Assessment
- Farley - The Landscape of Neonatal Anti-Infective Drug Development
- Mulugeta - Pharmacokinetic and Pharmacodynamic Considerations in Infants and Neonates
- Benjamin - Central Nervous System Infections and The Young Infant