Pediatric Research Equity Act of 2007 (PREA)
PREA Labeling Changes, Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505B of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA).
These assessments are for CBER regulated drugs approved under section 505 of the Act and biological drugs licensed under section 351 of the Public Health Service Act.
In accordance with section 505B(h)(1) of the Act as amended, links are provided in the table below to the medical, statistical, and clinical pharmacology reviews of pediatric assessments conducted under PREA. In accordance with section 505B(f)(6)(G) of the Act as amended, links are provided in the table below to currently approved labels (package inserts) that contain changes made as a result of a pediatric assessment.
| Product | Labeling and Reviews |
|---|---|
| Artiss Fibrin Sealant (Human) |
Package Insert Pharmacology / Toxicology Review Memorandum Statistical Review and Evaluation |
| Daptacel Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed |
Package Insert |
| Evicel Fibrin Sealant (Human) |
Package Insert |
| Rotarix Rotavirus Vaccine, Live, Oral |
Package Insert Clinical Review (PDF - 3.6 MB) Statistical Review and Evaluation Toxicology Review |
| Voluven 6% Hydroxyethyl Starch 130/0.4 in 0.9% Sodium Chloride Injection |
Package Insert PREA Review Memo Clinical Pharmacology |