Essentials of Healthcare Product Labeling
49
content of Pediatric Use information for the
prescribing information:
1. Evidence supports the safe and effective use
of the product in either all or specific pediat-
ric subpopulations – indication.
2. Evidence does not support the safe and
effective use of the product in either all or
specific pediatric subpopulations – study
negative or inconclusive – not indicated.
3. No evidence is available to support the safe
and effective use of the product in either all
or specific pediatric subpopulations – study
not conducted or ongoing or the studies
have been waived – not indicated.
4. Available evidence shows that the product is
contraindicated for use in all pediatric popu-
lations or a specific pediatric subpopulation.
Depending on which scenario described above
best fits the pediatric product information or
data accumulated by the sponsor, the information
or data may need to be included in additional
sections of the prescribing information, such as
indications and usage, dosage and administration,
adverse reactions, clinical pharmacology, clinical
studies, and contraindications (scenario #4 above).
Juvenile animal study data should be
concisely summarized in the Pediatric Use
subsection, under the heading Juvenile Animal
Toxicity Data, after all of the other required data
or information has been presented. The heading
should reflect that the data is the juvenile animal
study data and should only be included if a safety
signal has been discovered that was not addressed
previously. Sponsors should only include data
that has clinical relevance. If the nonclinical and
clinical data suggest a similar risk, the clinical
data should be discussed in the Pediatric Use
subsection, with a brief summary of the nonclin-
ical data. The summary of juvenile animal study
data should be discussed in clinically relevant
terms, such as:
• Human equivalent dose exposures
• Ages of animals and their correlation to
human ages
• Organ systems affected
• Duration of treatment of animals and the
relationship to clinical use
• Reversibility of the adverse effect and
• Developmental delay, if applicable.44
In general, there is no need to include a
description of juvenile animal studies in the
Nonclinical Toxicology section of the prescribing
information.
Conclusion
Labeling for a drug or biologic is a critical source
of information for healthcare professionals and
patients because it is used to ensure the proper
and safe use of the product. All labeling must be
truthful and accurate and only contain informa-
tion relevant to the indications for which the
product is approved. The FDA continues to refine
and update the required elements to be included
in the prescribing information, such as intro-
ducing a subsection for immunogenicity under
clinical pharmacology. All drug and biologic
manufacturers, sponsors, or NDA/BLA holders
must understand the labeling requirements for
their specific products. Not all sections of the
package insert are applicable to all drug and bio-
logic products for instance, the section on drug
abuse and dependence is typically not relevant
for biologics or biosimilars. Understanding the
requirements will enable the creation of compli-
ant labeling, which can decrease FDA comments
and lead to faster final label approval.
References
1. US Congress. Federal Food, Drug, and Cosmetic Act.
Dated 6 October 2023. Accessed 16 October 2023.
https://www.govinfo.gov/content/pkg/COMPS-973/
pdf/COMPS-973.pdf
2. Act to amend section 503(b) of the Federal Food, Drug,
and Cosmetic Act, HR 3298. 82nd cong. Accessed 16
October 2023. https://www.govinfo.gov/content/pkg/
STATUTE-65/pdf/STATUTE-65-Pg648.pdf
3. Drug Enforcement Agency. Controlled Substances
Act. Accessed 16 October 2023. https://www.dea.gov/
controlled-substances-act
4. Federal Trade Commission. Fair Packaging and
Labeling Act: Regulations Under Section 4 of the Fair
Packaging and Labeling Act. Accessed 16 October
2023. https://ftc.gov/legal-library/browse/rules/
fair-packaging-labeling-act-regulations-under-sec-
tion-4-fair-packaging-labeling-act
49
content of Pediatric Use information for the
prescribing information:
1. Evidence supports the safe and effective use
of the product in either all or specific pediat-
ric subpopulations – indication.
2. Evidence does not support the safe and
effective use of the product in either all or
specific pediatric subpopulations – study
negative or inconclusive – not indicated.
3. No evidence is available to support the safe
and effective use of the product in either all
or specific pediatric subpopulations – study
not conducted or ongoing or the studies
have been waived – not indicated.
4. Available evidence shows that the product is
contraindicated for use in all pediatric popu-
lations or a specific pediatric subpopulation.
Depending on which scenario described above
best fits the pediatric product information or
data accumulated by the sponsor, the information
or data may need to be included in additional
sections of the prescribing information, such as
indications and usage, dosage and administration,
adverse reactions, clinical pharmacology, clinical
studies, and contraindications (scenario #4 above).
Juvenile animal study data should be
concisely summarized in the Pediatric Use
subsection, under the heading Juvenile Animal
Toxicity Data, after all of the other required data
or information has been presented. The heading
should reflect that the data is the juvenile animal
study data and should only be included if a safety
signal has been discovered that was not addressed
previously. Sponsors should only include data
that has clinical relevance. If the nonclinical and
clinical data suggest a similar risk, the clinical
data should be discussed in the Pediatric Use
subsection, with a brief summary of the nonclin-
ical data. The summary of juvenile animal study
data should be discussed in clinically relevant
terms, such as:
• Human equivalent dose exposures
• Ages of animals and their correlation to
human ages
• Organ systems affected
• Duration of treatment of animals and the
relationship to clinical use
• Reversibility of the adverse effect and
• Developmental delay, if applicable.44
In general, there is no need to include a
description of juvenile animal studies in the
Nonclinical Toxicology section of the prescribing
information.
Conclusion
Labeling for a drug or biologic is a critical source
of information for healthcare professionals and
patients because it is used to ensure the proper
and safe use of the product. All labeling must be
truthful and accurate and only contain informa-
tion relevant to the indications for which the
product is approved. The FDA continues to refine
and update the required elements to be included
in the prescribing information, such as intro-
ducing a subsection for immunogenicity under
clinical pharmacology. All drug and biologic
manufacturers, sponsors, or NDA/BLA holders
must understand the labeling requirements for
their specific products. Not all sections of the
package insert are applicable to all drug and bio-
logic products for instance, the section on drug
abuse and dependence is typically not relevant
for biologics or biosimilars. Understanding the
requirements will enable the creation of compli-
ant labeling, which can decrease FDA comments
and lead to faster final label approval.
References
1. US Congress. Federal Food, Drug, and Cosmetic Act.
Dated 6 October 2023. Accessed 16 October 2023.
https://www.govinfo.gov/content/pkg/COMPS-973/
pdf/COMPS-973.pdf
2. Act to amend section 503(b) of the Federal Food, Drug,
and Cosmetic Act, HR 3298. 82nd cong. Accessed 16
October 2023. https://www.govinfo.gov/content/pkg/
STATUTE-65/pdf/STATUTE-65-Pg648.pdf
3. Drug Enforcement Agency. Controlled Substances
Act. Accessed 16 October 2023. https://www.dea.gov/
controlled-substances-act
4. Federal Trade Commission. Fair Packaging and
Labeling Act: Regulations Under Section 4 of the Fair
Packaging and Labeling Act. Accessed 16 October
2023. https://ftc.gov/legal-library/browse/rules/
fair-packaging-labeling-act-regulations-under-sec-
tion-4-fair-packaging-labeling-act