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.

Note: Documents in PDF format require the Adobe Acrobat Reader®. If you experience problems with PDF documents, please download the latest version of the Reader®.

Product Labeling and Reviews
Fibrin Sealant (Human)
Package Insert (PDF - 216 KB)
Pharmacology / Toxicology Review Memorandum
Statistical Review and Evaluation
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed
Package Insert (PDF - 247 KB)
Committee Chair Approval Memo
Clinical Review (PDF - 178 KB)
Fibrin Sealant (Human)
Package Insert (PDF - 171 KB)
Clinical Efficacy Supplement Final Review Memo (PDF - 319 KB)
Statistical Review and Evaluation
Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant
Package Insert (PDF, 464)
Clinical Review (PDF - 2.52 MB)
Statistical Review and Evaluation
Kogenate FS
Antihemophilic Factor (Recombinant)
Package Insert (PDF - 286 KB)
Final review memo (PDF - 396 KB)
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine
Package Insert (PDF - 92 KB)
Clinical Review (PDF - 748 KB)
Statistical Review (PDF - 271 KB)
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine
Package Insert (PDF - 379 KB)
Clinical Review (PDF - 1.4 MB)
Statistical Review (PDF - 188 KB)
Recommendations regarding request for partial waiver of pediatric studies
Rotavirus Vaccine, Live, Oral
Package Insert (PDF - 409 KB)
Clinical Review (PDF - 3.6 MB)
Statistical Review and Evaluation
Toxicology Review
6% Hydroxyethyl Starch 130/0.4 in 0.9% Sodium Chloride Injection
Package Insert (PDF - 233 KB)
PREA Review Memo
Clinical Pharmacology


Updated: October 29, 2008