Description
This guidance is intended to assist applicants in preparing the CLINICAL PHARMACOLOGY section of prescription drug labeling (henceforth referred to as labeling) to meet regulatory requirements and ensure appropriate consistency in the format and content of this section for all prescription drugs approved by FDA.
Scope & Applicability
Product Classes
2Products including previously approved individual components
Requires analytical comparability per ICH Q5E
Stakeholders
1Entity submitting development data and knowledge; Entity performing the work process for change
Regulatory Context
Attributes
7Presentation of information in labeling
time to reach peak exposure
Property used to determine maintenance dose intervals and safety monitoring
AUC or Cmin may correlate with efficacy
Cmax may be more informative for safety
Time to stable PD effect
Nature of the PD effect dependency
Identified Hazards
Hazards
1Assessment of toxicity required in a 351(k) BLA
Related CFR Sections (3)
- 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 →
- 21CFR314.70§ 314.70 Supplements and other changes to an approved NDA.
(a) Changes to an approved NDA.Read full regulation →
- 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 →
See Also (8)
- Geriatric Information in Human Prescription Drug and Biological Product Labeling Guidance for Industry: Draft Guidance for Industry (Status: Draft)
- Clinical Pharmacology Considerations for Peptide Drug Products (Status: Draft)
- Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use: Guidance for Industry (Status: Final)
- Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format (Status: Draft)
- Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products-Content and Format: Draft Guidance for Industry (Status: Draft)
- Drug Interaction Information in Human Prescription Drug and Biological Product Labeling (Status: Draft)
- Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products — Content and Format (Status: Final)
- Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products — Content and Format: Guidance for Industry (Status: Final)