FDA Logo links to FDA home page
Center for Drug Evaluation and Research, U.S. Food and Drug AdministrationU.S. Food and Drug AdministrationCenter for Drug Evaluation and Research
  HHS Logo links to Department of Health and Human Services website

FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER

horizonal rule

CDER Home About CDER Drug Information Regulatory Guidance CDER Calendar Specific Audiences CDER Archives
 
Powered by Google
 

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

back to top

Pediatric Research Equity Act (PREA)

back to top

Guidances for Industry

back to top

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]

back to top

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

back to top

Counter-Terrorism Measures for Use in Pediatrics

back to top

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

2003

2002

2001

2000

1999

1998

back to top

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.

back to top

Historical References

back to top

Other Resources

How to Contact Us

Back to Top

PDF document PDF requires the free Adobe Acrobat Reader.

Date created: March 19, 2003; Last updated: August 29, 2008

horizonal rule