Description
This guidance is intended to assist applicants in determining the appropriate placement and content of pediatric information in human prescription drug and biological product labeling as described in the regulations for the content and format of labeling for human prescription drug and biological products.
Scope & Applicability
Product Classes
2guidance applies to drugs regulated under section 505
Regulated under section 351(i) of the PHS Act; Virus, therapeutic serum, toxin, vaccine, or protein applicable to prevention or treatment; Alternative regulation category for products meeting device definition
Stakeholders
3Entities submitting supplements to BLAs
REMS program requires training be made available to all health care providers.
Entity responsible for submitting applications under section 524B
Regulatory Context
Attributes
3background on pediatric age groups
Scenario where drug is prohibited for use in specific pediatric groups
Clinically relevant term for summarizing animal data
Identified Hazards
Hazards
1Potential risk that may lead to removal of a device type from the pathway list.
Related CFR Sections (2)
- 21CFR201.56§ 201.56 Requirements on content and format of labeling for human prescription drug and biological products.
(a) General requirements. Prescription drug labeling described in § 201.100(d) must meet the following general requirements:Read full regulation →
- 21CFR201.57§ 201.57 Specific requirements on content and format of labeling for human prescription drug and biological products described in § 201.56(b)(1) .
The requirements in this section apply only to prescription drug products described in § 201.56(b)(1) and must be implemented according to the schedule specified in § 201.56(c) , except for the requirement in paragraph (c)(18) of this section to reprint any FDA-approved patient labeling at the end oRead full regulation →
See Also (8)
- Labeling for Human Prescription Drug and Biological Products - Implementing the PLR Content and Format Requirements (Status: Final)
- Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products — Content and Format (Status: Final)
- Labeling for Biosimilar Products Guidance for Industry (Status: Final)
- The “Deemed to be a License” Provision of the BPCI Act: Questions and Answers : Guidance for Industry (Status: Final)
- Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products-Content and Format: Draft Guidance for Industry (Status: Draft)
- Geriatric Information in Human Prescription Drug and Biological Product Labeling Guidance for Industry: Draft Guidance for Industry (Status: Draft)
- QTc Information in Human Prescription Drug and Biological Product Labeling: Draft Guidance for Industry (Status: Draft)
- Drug Interaction Information in Human Prescription Drug and Biological Product Labeling (Status: Draft)