Advertisement

Labeling of Drug and Biologic Products for Pediatric Use

  • 6 Citations

Abstract

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.

This is a preview of subscription content, log in to check access.

Access options

Buy single article

Instant unlimited access to the full article PDF.

US$ 39.95

Price includes VAT for USA

Subscribe to journal

Immediate online access to all issues from 2019. Subscription will auto renew annually.

US$ 189

This is the net price. Taxes to be calculated in checkout.

References

  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.

  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.

  3. 3.

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

  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.

  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.

  6. 6.

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

  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.

  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.

  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.

  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 http://www.fda.gov)

  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 http://www.fda.gov)

Download references

Author information

Correspondence to Dr. Emily Shacter PhD.

Rights and permissions

Reprints and Permissions

About this article

Cite this article

Shacter, E., DeSantis, P.L. Labeling of Drug and Biologic Products for Pediatric Use. Ther Innov Regul Sci 32, 299–303 (1998) doi:10.1177/009286159803200140

Download citation

Key Words

  • Drugs
  • Biologies
  • Labeling
  • Pediatrics
  • Regulations