Pediatric exclusivity

REASON FOR SUBMISSION This section should contain a brief explanation of the submission, e.g., "manufacturing change from roller bottle to cell factory" or "response to Information Request Letter of 1/9/97" or "Pediatric exclusivity determination request" or "to satisfy a subpart H postmarketing commitment". 

The success of the various special-case areas of drug development regulation and performance, such as orphan drugs, cancer, and AIDS drugs, and the pediatric exclusivity extension could be a guide to how to approach - and what to avoid -in creating larger facilitatory approaches in the future. 

Although the pediatric exclusivity provisions of the FDAMA, and the BPCA, represent a voluntary program, they have proved to be the first successful stimulus to the conduct of pediatric studies. 

Health Research Group (HRG). 2001. Pediatric Exclusivity Changes Needed to Assure Safety and Effectiveness of Medications for Children and More Affordable Drugs for Seniors. Washington, DC Public Citizen. 

B) a statement of any appropriate pediatric contraindications, warnings, or precautions that the Secretary considers necessary. (3) PRESERVATION OF PEDIATRIC EXCLUSIVITY AND OTHER PROVISIONS. This subsection does not affect... 

The FDA provides notice of the innovator s FDA and patent exclusivity by publishing information regarding exclusivity in the FDA Approved Drugs Product List (the Orange Book ). The Patent and Exclusivity Appendix to the list of approved products provides details regarding the expiry dates of all types of FDA exclusivity (including pediatric exclusivity) and the expiry dates of patents for each approved product. 

Department of Health and Human Services (2001). The pediatric exclusivity provision - January 2001 status report to congress. Food and Drug Administration, 2001. http //www.fda.gov/cder/pediatric/reportcong01.pdf (accessed January 2006). 

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