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Pediatric Drug Development
Contents:
FDA Amendments Act of 2007 (FDAAA)
Best Pharmaceuticals for Children Act (BPCA)
- Best Pharmaceuticals for Children Act, January 4, 2002 (Public Law No. 107-109). [HTML] [PDF]
BPCA/Pediatric Exclusivity
BPCA/Pediatric Exclusivity Statistics
Best Pharmaceuticals for Children Act of 2007 (BPCA of 2007)
FDAMA and Best Pharmaceuticals for Children Act of 2002
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)
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Guidances for Industry
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Regulations
- 1994 Pediatric Final Rule: Specific Requirements on Content and Format of Labeling for Human Prescription Drugs; Revision of "Pediatric Use" Subsection in the Labeling. (21 CFR Part 201)
- Interim Rule: Additional Safeguards for Children in Clinical Investigations of FDA-Regulated Products [HTML][PDF]
- 21 CFR 201.57 Specific Requirements on Content and Format of Labeling for Human Prescription Drugs [HTML] [PDF]
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Pediatric Advisory Committee
Advisory Subcommittee of the Anti-Infective Drugs Advisory Committee
FDA Pediatric Ethics Working Group Consensus Statement on the 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: Pediatric Exclusivity Labeling Changes).
2004
- The Role of the FDA in Pediatric Research - July 16, 2004, Dianne Murphy, M.D. Presented at the Glaser Pediatric Research Network Symposium
- 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.
- Impact of Pediatric Initiatives - June 15, 2004, Dianne Murphy, M.D. Presented at the Drug Information Association Annual Meeting.
- FDA Perspective on FDAMA: Successes, Failures; Future Directions - May 3, 2004, Rosemary Roberts, M.D.
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
- 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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Date created: March 19, 2003; Last updated: January 15, 2008 |
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