Labeling of Drug and Biologic Products for Pediatric Use


Drugs and biological therapeutics are commonly prescribed to pediatric patients in the absence of adequate dosage and administration information in the product label. This paper describes issues surrounding labeling of drugs and biologies for pediatric use. It includes a discussion of why drugs and biologies should be labeled with pediatric use information, an update on the status of regulatory guidance for pediatric labeling, and a summary of recent steps taken by the Food and Drug Administration (FDA) to increase the number of therapeutic products that contain appropriate labeling for pediatric use.

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  1. 1.

    Committee on Drugs, American Academy of Pediatrics. Guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations. Pediatrics. 1995;95(2):286–294.

    Google Scholar 

  2. 2.

    Food and Drug Administration. Specific requirements on content and format of labeling for human prescription drugs; revision of “pediatric use” subsection in the labeling; final rule. Federal Register. 1994;59(December 13):64240–64250.

    Google Scholar 

  3. 3.

    Gupta A, Waldhauser LK. Adverse drug reactions from birth to early childhood. Ped Clin North Am. 1997;44:79–92.

    CAS  Article  Google Scholar 

  4. 4.

    Food and Drug Administration. Pediatric Patients; Regulations Requiring Manufacturers To Assess the Safety and Effectiveness of New Drugs and Biological Products. Federal Register. 1997;62(158) (August 15):43900–43916.

    Google Scholar 

  5. 5.

    Dreifuss FE, Santilli N, Langer DH, Sweeney KP, Moline KA, Menander KB. Valproic acid hepatic fatalities: A retrospective review. Neurology. 1987; 37:379–385.

    CAS  Article  Google Scholar 

  6. 6.

    Powell DA, Nahata MC. Chloramphenicol: New perspectives on an old drug. Drug Intell Clin Pharm. 1982;16:295–300.

    CAS  Article  Google Scholar 

  7. 7.

    Aranda JV, Chemtob S, Laudignon N, Sasyniuk BI. Pharmacologic effects of theophylline in the newborn. J Allergy Clin Immunol. 1986;78(4):773–780.

    CAS  Article  Google Scholar 

  8. 8.

    Berthou F, Ratanasavanh D, Alix D, Carlhant D, Riche C, Guillouzo A. Caffeine and theophylline metabolism in newborn and adult human hepato-cytes; comparison with rat hepatocytes. Biochem Pharmacol. 1988;37(19):3691–3700.

    CAS  Article  Google Scholar 

  9. 9.

    Food and Drug Administration. Labeling and pre-scription drug advertising: content and format for labeling for human prescription drugs. Federal Register. 1979;44(June 26):37434–37467.

    Google Scholar 

  10. 10.

    Food and Drug Administration.Guidance for Industry: The Content and Format for Pediatric Use Supplements.” May 1997. (An electronic version of this document can be obtained via Internet using the address

    Google Scholar 

  11. 11.

    Pina LM. Center IDs top 10 drugs used off-label in outpatient setting. The Pike 1997;(Ianuary 17):6–7. (News Along the Pike is the CDER Newsletter. An electronic version of this document can be obtained via Internet using the address

    Google Scholar 

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Correspondence to Dr. Emily Shacter PhD.

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Shacter, E., DeSantis, P.L. Labeling of Drug and Biologic Products for Pediatric Use. Ther Innov Regul Sci 32, 299–303 (1998).

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Key Words

  • Drugs
  • Biologies
  • Labeling
  • Pediatrics
  • Regulations