ABSTRACT
Pediatric Research Equity Act (PREA) amends the Federal Food, Drug, and Cosmetic Act (the Act) by adding Section 505B. PREA requires the conduct of pediatric studies for certain drug and biological products. Specifically, PREA requires new drug applications and biologics licensing applications for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration to contain a pediatric assessment unless the applicant has obtained a waiver or deferral. It also authorizes Food and Drug Administration (FDA) to require holders of applications for previously approved marketed drugs and biological products who are not seeking approval for one of the changes enumerated above to submit a pediatric assessment under certain circumstances. In PREA, Congress codified many of the elements of the Pediatric Rule, a final rule issued by FDA on December 2, 1998 and suspended by court order on October 17, 2002.
