Food and Drug Administration
March 4, 2003
Briefing Information
Guidance for Industry, General Considerations for the Clinical Evaluation of Drugs in Infants and Children (PDF)
Guidance for Industry, The Content and Format for Pediatric Use Supplements (PDF)
Guidance for Industry, Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products (PDF)
Guidance for Industry, General Considerations for Pediatric Pharmacokinetic Studies for Drugs and Biologcial Products (PDF)
Pediatric Rule (HTM) (PDF) (Word)
Guidance for Industry, Recommendations for Complying With the Pediatric Rule (21 CFR 314.55(a) and 601.27 (a)) (PDF)
Guidance for Industry, E11 Clinical Investigation of Medicinal Products in the Pediatric Population (PDF)
Labeling Requirements for Prescription Drugs and/or Insulin (HTM) (PDF) (Word)
Guidance for Industry, Clinical Studies Section of Labeling for Prescription Drugs and Biologics--Content and Format (PDF)
Guidance for Industry, Format and Content of Clinical Pharmacology Section of Human Prescription Drug Labeling (PDF)
Best Pharmaceuticals for Children Act (PDF)
Annotated Reading List (HTM) (PDF) (Word)
Bibliography (HTM) (PDF) (Word)
Open Public Hearing
Statement of Edward Allera, Esq., Dealing with Oncology Data in Drug Labeling and Beyond (PDF)