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Pediatric
Drug Development
Contents:
Best Pharmaceuticals for Children Act
(BPCA)
BPCA/Pediatric Exclusivity
BPCA/Pediatric Exclusivity Statistics
Written Request Templates
BPCA/Off-Patent Drugs
BPCA/Access
to New Therapeutic Agents for Pediatric Cancer
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Pediatric
Research Equity Act (PREA)
Documents/Information Related to the Pediatric Rule
Pediatric Rule Statistics
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Guidances for Industry
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Regulations
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Pediatric Advisory Subcommittee of the Anti-Infective Drugs Advisory Committee
Consensus Statements from Pediatric Advisory Subcommittee Meetings
Meetings of the Subcommittee
- March 3, 2003
- June 11, 2002
- April 23-24,
2001
- September 11-12, 2000
- November 15-16,
1999
- April 23, 1999
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Counter-Terrorism Measures for Use in Pediatrics
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Presentations by CDER Staff on Pediatric Issues
(Presentation slides do not provide
complete information regarding labeling changes. For more complete labeling
change information, including hyperlinks to the labeling of most products
referenced in the presentation, please see: http://www.fda.gov/cder/pediatric/labelchange.htm.)
2004
- The Role of the FDA in Pediatric Research – July 16, 2004, Dianne
Murphy, M.D. Presented at the
Glaser Pediatric Research Network Symposium (posted 9/2/2004)
- Regulatory Framework for Pediatric Drug Development in the U.S. – June 16, 2004, Shirley Murphy, M.D. Presented at
the Drug Information Association Annual Meeting. (posted 6/24/2004)
- Impact of
Pediatric Initiatives – June 15, 2004, Dianne Murphy, M.D. Presented at
the Drug Information Association Annual Meeting. (posted 6/16/2004)
- FDA Perspective on FDAMA: Successes, Failures; Future Directions
– May 3, 2004, Rosemary Roberts, M.D.
(posted 6/1/2004)
2003
- Pediatric Advisory Subcommittee of the Anti-Infective Drugs Advisory
Committee, June 12, 2003:
- Drug Information Association Meeting: "Pediatric Studies
Initiative" March
27-28, 2003:
- Pediatric Advisory Subcommittee of the Anti-Infective Drugs Advisory Committee, March 3, 2003:
2002
2001
2000
1999
- Pediatric
Initiatives Update, Murray M. Lumpkin, M.D., October 20, 1999
- Pediatric
Initiatives, 1999 Regulatory Affairs Professional Society Annual Conference:
Leanne Cusumano, Regulatory Counsel, CDER
(10/13/1999)
- Drug Information Association, Annual Meeting, 1999:
- 1999 Pediatric Initiatives, Dianne
Murphy, M.D., Associate Director for Pediatrics (posted 7/02/1999)
- Pediatric
Subcommittee; Anti-Infective Drugs Advisory Committee, 4/23/1999
- 1999 Food & Drug Law Institute Annual
Education Conference - Exclusivity: Pediatrics & 505(b)(2)s, Leanne Cusumano
(1/14/2000)
1998
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Organization
The Division of Pediatric Drug Development (DPDD) is part of the
Office of Counter-Terrorism and Pediatric Drug Development (OCTAP), in the
Office of the Center Director, CDER.
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Historical References
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Other Resources
How to Contact Us
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FDA/Center for Drug Evaluation and Research
Last Updated: November 15, 2004
Originator: OCTAP/DPDD
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