FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER
Regulatory Framework for Pediatric Drug Development in the U.S. June 16, 2004
Click here to start
Regulatory Framework for Pediatric Drug Development in the US
Overview
General Principles*
Historical Perspective
BENCHMARKS: Pediatric Drug Development
Goal
BPCA Provisions
BPCA On-Patent Drugs and “2nd pathway”
Written Request (WR)
Criteria for WR
Process for the Study of On-Patent Drugs
FDA On-Patent Drug Exclusivity Process
Murphy’s Laws for obtaining Exclusivity
Pediatric Exclusivity
“2nd Pathway” - On-Patent Drugs referred to NIH Foundation
BPCA - Off-Patent Drugs
An FDA/NIH Partnership
FDA/NIH Partnership
Process for the Study of Off-Patent Drugs
Written Requests Issued for Off-Patent Drugs
Pediatric Research Equity Act
PREA
PREA vs. Rule
PREA vs. BPCA
Interaction of PREA and BPCA
Summary
FDA Web Page
Pediatric Web Page
To Contact Us:
Presented: June 16, 2004 Drug Information Association Annual Meeting
Download presentation source (PowerPoint format)
Back to Top Back to Pediatric Drug Development
Date created: June 24, 2004
CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | Privacy | Accessibility | HHS Home Page
FDA/Center for Drug Evaluation and Research
