Description
This guidance is intended to assist applicants of human prescription drug and biological products in determining the appropriate placement and content of geriatric information in labeling as described in the regulations for the content and format of labeling for human prescription drug and biological products. , The goal of this guidance is to provide recommendations to help ensure that appropriate information on the use of prescription drugs in geriatric patients is consistently placed in the proper sections and subsections within labeling so that the information is clear and accessible to health care practitioners and includes content that guides the safe and effective use in geriatric patients.
Scope & Applicability
Product Classes
3guidance 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
Systemic absorption is usually minimal in geriatric patients
Stakeholders
3Entity submitting development data and knowledge; Entity performing the work process for change
Target population for specific labeling information
Entities submitting supplements to BLAs
Regulatory Context
Attributes
4Specific subsection within labeling for geriatric information
Narrow margins may necessitate dose adjustments
Level at which ingredients enter the bloodstream
65-74 years, 75-84 years, and 85 years and older
Identified Hazards
Hazards
3Specific risk in geriatric patients
Risks associated with drug use in geriatric patients
Specific risk in geriatric patients
Related CFR Sections (3)
- 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 →
- 21CFR314.50§ 314.50 Content and format of an NDA.
NDAs and supplements to approved NDAs are required to be submitted in the form and contain the information, as appropriate for the particular submission, required under this section. Three copies of the NDA are required: An archival copy, a review copy, and a field copy. An NDA for a new chemical enRead 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)
- Pediatric Information Incorporated Into Human Prescription Drug and Biological Products Labeling Good Review Practice (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)
- 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)