About FDA

Biologics PREA Reviews and Labeling Changes

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.

ProductApproval DatesLabeling and Reviews
Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method
12/14/2011Package Insert (PDF - 511KB)
Clinical Review(PDF - 23KB)
Statistical Review and Evaluation (PDF - 389KB)
Antihemophilic Factor (Recombinant), PEGylated
12/22/2016Package Insert (PDF - 655KB)
Statistical Review (PDF - 240KB)
Clinical Review (PDF - 1.7 MB)
11/13/2015Package Insert (PDF - 655KB)
Statistical Review (PDF - 343KB)
Clinical Review (PDF - 1.3MB)
Influenza Virus Vaccine
10/4/2018Package Insert (PDF - 359KB)
11/10/2009Package Insert (PDF - 282 KB)
Statistical Review (PDF - 45KB)
Clinical Review (PDF - 803KB)
Influenza Vaccine
10/4/2018Package Insert (PDF - 352KB)
Clinical Review (PDF - 1.1 MB)
Statistical Review (PDF - 533KB)
Statistical Review Addendum (PDF - 256KB)
8/31/2017Package Insert (PDF - 279KB)
Clinical Review (PDF - 965KB)
Statistical Review (PDF - 351KB)
Antihemophilic Factor (Recombinant), Single Chain
5/25/2016Package Insert (PDF - 289 KB)
Statistical Review (PDF - 1 MB)
Clinical Review (PDF - 1.3 MB)
Fibrin Sealant (Human)
3/19/2008Package Insert (PDF - 216 KB)
Statistical Review and Evaluation
Clinical Review (PDF - 808 KB)
Meningococcal Group B Vaccine
1/23/2015Package Insert(PDF-141KB)
Statistical Review (PDF-322KB)
Clinical Review (PDF - 1MB)
Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant
7/14/2011Statistical Review and Evaluation (PDF - 87KB)
Clinical Review (PDF - 372KB)
10/16/2009Package Insert (PDF - 235 KB)
Statistical Review and Evaluation
Clinical Review Memo  (PDF - 16.9MB)
Immune Globulin Subcutaneous (Human), 20% Solution
9/13/2016Package Insert (PDF - 606 KB)
Clinical Review (PDF - 1.4MB)
Statistical Review (PDF - PDF - 1.7MB)
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed
3/12/2008Package Insert (PDF - 247 KB)
Clinical Review (PDF - 178 KB)
Fibrin Sealant (Human)
1/2/2008Package Insert (PDF - 164 KB)
Clinical Efficacy Supplement Final Review Memo (PDF - 319 KB)
Statistical Review and Evaluation
Fibrinogen (Human)
6/7/2017Package Insert (PDF - 221KB)
Clinical Review (PDF - 863 KB)
Statistical Review (PDF - 234 KB)
Influenza Virus Vaccine
10/19/2009Package Insert (PDF - 181KB)
Statistical Review and Evaluation
Clinical Review  
Fluarix Quadrivalent
Influenza Virus Vaccine
1/11/2018Package Insert (PDF - 585 KB)
Clinical Review (PDF - 1.2 MB)
Statistical Review (PDF - 242 KB)
12/14/2012Package Insert (PDF-259KB)
Clinical Review (PDF - 818KB)
Statistical Review and Evaluation (PDF - 2.4MB)
Influenza Vaccine
5/23/2016Package Insert (PDF - 285 KB)
Statistical Review (PDF - 323 KB)
Clinical Review Addendum (PDF - 158 KB)
Flucelvax Quadrivalent
Influenza Vaccine
5/23/2016Package Insert (PDF - 193 KB)
Clinical Review (PDF - 679 KB)
Statistical Review Addendum (PDF - 31KB)
Statistical Review (PDF - 464KB)

Influenza Virus Vaccine
11/18/2016Package Insert  (PDF - 245KB)
Clinical Review (PDF - 523KB)
Statistical Review and Evaluation (PDF - 150KB)
Statistical Review Assay (PDF - 71KB)
8/16/2013Package Insert (PDF - 206KB)
Clinical Review (PDF - 800KB)
Statistical Review and Evaluation (PDF - 163KB)

FluLaval Quadrivalent
Influenza Virus Vaccine
11/18/2016Package Insert (PDF - 261KB)
Clinical Review (PDF - 523KB)
Statistical Review and Evaluation (PDF - 150KB)
Statistical Review Assay (PDF - 71KB)
8/15/2013Package Insert (PDF - 298KB)
Statistical Review and Evaluation (PDF-288KB)
Final Clinical Review (PDF - 2.5MB)
FluMist® Quadrivalent
Influenza Vaccine Live, Intranasal 
2/29/2012Package Insert (PDF - 625KB)
Clinical Review (PDF - 576KB)
Statistical Review and Evaluation (PDF - 106KB)
Fluzone Quadrivalent
Influenza Virus Vaccine
6/7/2013Package Insert (PDF -356KB)
Clinical Review (PDF - 970KB)
Statistical Review and Evaluation (PDF - 222KB)
Gammagard Liquid
Immune Globulin Intravenous (Human), 10% Solution
7/22/2011Package Insert (PDF - 577KB)
Clinical Review (PDF - 371KB)
Statistical Review and Evaluation (PDF - 89KB)
Immune Globulin Intravenous (Human) 5% Liquid
7/30/2015Package Insert (PDF - 333KB)
Clinical Review (PDF - 3.1MB)
Statistical Review (PDF - 170KB)
Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified
12/4/2015Package Insert (PDF-741KB)
Clinical Review (PDF -581KB)
Clinical Pharmacology Review (PDF-473KB)
Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant
12/22/2010Package Insert (PDF - 460KB)
Clinical Review (PDF - 454KB)
Statistical Review and Evaluation (PDF - 464 KB)
10/16/2009Package Insert (PDF - 470 KB)
Clinical Review (PDF - 611 KB)
Statistical Review (PDF - 202 KB)
9/12/2008Package Insert (PDF - 464 KB)
Clinical Review (PDF - 2.52 MB)
Statistical Review and Evaluation
Gardasil 9
Human Papillomavirus 9-valent Vaccine, Recombinant
10/7/2016Package Insert (PDF - 325KB)
Clinical Review (PDF - 395KB)
Statistical Review (PDF - 409KB)
12/10/2014Package Insert (PDF-256KB)
Clinical Review (PDF - 1.4MB)
Statistical Review (PDF - 931KB)
Timothy Grass Pollen Allergen Extract
4/11/2014Package Insert (PDF - 173KB)
Clinical Review (PDF - 1.2MB)
Statistical Review (PDF - 2MB)
Hematopoietic progenitor cells, cord blood
11/10/2011Package Insert (PDF - 312 KB)
Clinical and Statistical Joint Review (PDF - 609KB)
Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)
1/14/2016Package Insert (PDF - 212KB)
Clinical Review (PDF - 676KB)
Statistical Review (PDF - 680KB)
8/19/2009Package Insert (PDF - 166 KB)
Clinical Review (PDF - 934 KB)
Statistical Review (PDF - 875 KB)

Immune Globulin Subcutaneous (Human), 20% Liquid

9/25/2013Package Insert (PDF-534KB)
10/3/2011Package Insert (PDF-564 KB)
Statistical Review and Evaluation (PDF - 161KB)
Clinical Review (PDF- 124KB)
2/17/2011Package Insert (PDF - 546 KB)
Clinical Review (PDF-227KB)
Japanese Encephalitis Vaccine, Inactivated, Adsorbed
4/13/2018Package Insert (PDF - 349KB)
Clinical Review (PDF - 380KB)
Statistical Review (PDF - 234KB)
5/17/2013Package Insert (PDF - 286KB)
Clinical Review (PDF - 743KB)
Statistical Review and Evaluation (PDF - 777KB)
Coagulation Factor IX (Recombinant)
4/29/2015Package Insert (PDF-500KB)
Clinical Review 1 (PDF - 2.6MB)
Clinical Review 2 (PDF - 2.3MB)
Clinical Review 3 (PDF - 3.6MB)
Statistical Review and Evaluation (PDF - 1018KB)
Antihemophilic Factor (Recombinant), PEGylated-aucl
8/29/2018Package Insert (PDF-503 KB)
Clinical Review (PDF - 729 KB)
Statistical Review (PDF - 1.4 MB)
Albumin (Human) 25%
6/3/2011Package Insert (PDF - 216KB)
Clinical Review (PDF - 314KB)
Statistical Review and Evaluation (PDF - 85KB)
Kogenate FS
Antihemophilic Factor (Recombinant)
10/10/2008Package Insert (PDF - 286 KB)
Clinical Review (PDF - 396 KB)
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine
6/24/2008Package Insert (PDF - 92 KB)
Clinical Review (PDF - 748 KB)
Statistical Review (PDF - 271 KB)
Antihemophilic Factor (Recombinant)
3/16/2016Package Insert (Vial Adapter) (PDF-412KB)
Package Insert (BIO-SET) (PDF-567KB)
Clinical Review (PDF-2.5 MB)
Statistical Review (PDF-7.2 MB)

Meningococcal Polysaccharide (Serogroups A, C, Y and W-135) Diphtheria Toxoid Conjugate Vaccine

4/22/2011Package Insert (PDF - 296KB)
Clinical Review (PDF - 337KB)
Statistical Review (PDF - 531KB)
Pharmacovigilance Plan Review (PDF - 25KB)
Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine
6/14/2012Package Insert (PDF - 124KB)
Statistical Review and Evaluation
Clinical Review (PDF - 1.4MB)
Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine
8/1/2013Package Insert (PDF - 205 KB)
Clinical Review (PDF - 682KB)
Statistical Review (PDF - 783KB)
1/28/2011Package Insert (PDF - 205 KB)
Clinical Review (PDF - 105MB)
Statistical Review (PDF - 620KB)
2/19/2010Package Insert (PDF - 205 KB)
Clinical Review (PDF - 759 KB)
Statistical Review
Antihemophilic Factor (Recombinant
10/15/2013Package Insert - Novoeight (PDF - 455KB)
Clinical Review (PDF-715KB) Statistical Review and Evaluation
Antihemophilic Factor (Recombinant)
9/4/2015Package Insert (PDF - 354KB)
Clinical Review (PDF - 1.4MB)
Statistical Review (PDF - 1.6MB)
Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract
11/9/2018Package Insert & Medication Guide(PDF - 240KB)
Statistical Review (PDF - 555KB)
Clinical Review Memo (PDF - 395KB)
4/1/2014Package Insert (PDF - 284KB)
Statistical Review (PDF-4.4MB)
Clinical Review (PDF - 2.7MB)
Immune Globulin Intravenous, human-ifas
8/2/2018Package Insert (PDF - 227KB)
Clinical Review (PDF - 983 KB)
Statistical Review (PDF - 913KB)
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine
6/20/2008Package Insert (PDF - 379 KB)
Clinical Review (PDF - 1.4 MB)
Statistical Review (PDF - 188 KB)

Recommendations regarding request for partial waiver of pediatric studies

Prevnar 13
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
1/25/2013Package Insert (PDF - 747KB)
Clinical Review (PDF - 672KB)
Statistical Review and Evaluation (PDF-638KB)
2/24/2010Package Insert (PDF - 473 KB)
Clinical Review (PDF - 12346 KB)
Statistical Review and Evaluation (PDF - 1114 KB)
Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
9/9/2016Package Insert (PDF - 174KB)
Clinical Review (PDF - 845KB)
Statistical-Clinical Review (PDF - 395KB)
Statistical-Clinical Review - Addendum (PDF - 92KB)
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine
3/24/2015Package Insert ( PDF - 177 KB)
Clinical Serology and Bioassay Review, and Approval Memo (PDF - 307KB)
Clinical Statistical Review (PDF - 408KB)
Coagulation Factor IX (Recombinant), GlycoPEGylated
5/31/2017Package Insert (PDF-424 KB)
Clinical Review (PDF - 1.6MB)
Statistical Review (PDF - 1.8MB)
Thrombin, topical (Recombinant)
3/15/2013Package Insert (PDF - 201KB)
Clinical Review (PDF - 206KB)
Final Clinical Labeling Memo (PDF - 52KB)
Coagulation Factor IX (Recombinant)
9/12/2014Package Insert (PDF - 358KB)
Clinical Review (PDF - 361KB)
Statistical Review (PDF - 368KB)
Rotavirus Vaccine, Live, Oral
4/3/2008Package Insert (PDF - 409 KB)
Clinical Review (PDF - 3.6 MB)
Statistical Review and Evaluation 
Rotavirus Vaccine, Live, Oral, Pentavalent
2/23/2017Package Insert (PDF-172KB)
Clinical Review (PDF-339KB)
Statistical Review (PDF-331KB)
Rubber Panel T.R.U.E. TEST
Rubber Panel Thin-Layer Rapid Use Epicutaneous Patch Test
3/3/2017Package Insert (PDF-234KB)
Clinical Review (PDF-1.3MB)
Statistical Review (PDF-633 KB)
TACHOSIL® Fibrin Sealant Patch
7/15/2015Package Insert (PDF - 584KB)
Clinical Review (PDF - 1013KB)
Statistical Review (PDF - 1.6 MB)
Fibrin Sealant
1/25/2012Package Insert (PDF - 113KB)
Clinical Review (PDF - 415KB)
Statistical Review and Evaluation (PDF - 78.8KB)
Thin-Layer Rapid Use Epicutaneous Patch Test
8/25/2017Package Insert (PDF - 424KB)
Clinical Review (PDF - 435KB)
Statistical Review (PDF - 527KB)
Meningococcal Group B Vaccine
4/14/2016Package Insert (PDF-391KB)
Clinical Review (PDF-474KB)
Statistical Review (PDF-479KB)
Addendum to Statistical Review (PDF-57KB)
10/29/2014Package Insert (PDF-391KB)
Clinical Review (PDF - 856KB)
Statistical Review (PDF - 1 MB)
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine
12/21/2018Package Insert (PDF - 367KB)
Clinical Review (PDF - 2MB)
Statistical Review (PDF - 529KB)

6% Hydroxyethyl Starch 130/0.4 in 0.9% Sodium Chloride Injection
5/17/2012Package Insert (PDF - 223KB)
Clinical Review (BN070012/145) (PDF - 62KB)
Statistical Review and Evaluation (BN070012/145) (PDF - 120KB)
12/27/2008Package Insert (PDF - 233 KB)
Clinical PREA Review Memo
Clinical Pharmacology
von Willebrand Factor/Coagulation Factor VIII Complex (Human)
8/5/2015Package Insert (PDF - 367KB)
Clinical Review (PDF - 889KB)
Statstical Review (PDF - 1.5MB)


Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002

Page Last Updated: 02/12/2019
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