1.2.5 — Prescribing Information / Labeling

Prescribing information and approved labeling for NDA

Requirements by Phase

NDA: required

Content Requirements

• Draft prescribing information per 21 CFR 201.56-57 (NDA only)
• Highlights of prescribing information
• Full prescribing information including indications, dosage, warnings, precautions, adverse reactions, drug interactions, use in specific populations
• Patient labeling (Medication Guide or Patient Package Insert if applicable)
• For IND: Investigator's Brochure serves this purpose instead

Expected Deliverables

• Draft package insert
• Patient labeling

ICH Guidelines: 21 CFR 201.56, 21 CFR 201.57

Regulatory Requirements (FDA IND PHASE 1)

• [Phase 1] A mock-up or printed representation of the proposed labeling that will be provided to investigator(s) in the proposed clinical trial should be submitted.

Regulatory Requirements (FDA IND PHASE 2 3 CMC)

• [Phase 3] A brief description of the packaging and labeling process for clinical supplies should be provided in an annual report.
• [Phase 2, Phase 3] Updates of the information provided for phase 1 labeling should be submitted in information amendments during phase 2 and phase 3.

Regulatory Requirements (ICH Q1AR2)

• [Pre-approval] A storage statement should be established for the labeling in accordance with relevant national/regional requirements, based on the stability evaluation of the drug substance.
• [Pre-approval] Terms such as “ambient conditions” or “room temperature" should be avoided in drug substance labeling.
• [Pre-approval] Stability testing of the drug product after constitution or dilution, if applicable, should be conducted to provide information for the labeling on the preparation, storage condition, and in-use period.
• [Pre-approval] A storage statement should be established for the labeling in accordance with relevant national/regional requirements, based on the stability evaluation of the drug product.
• [Pre-approval] Terms such as "ambient conditions” or “room temperature" should be avoided in drug product labeling.

Regulatory Requirements (ICH Q1B)

• [Registration] The formal labeling requirements for photolabile drug substances and drug products are established by national/regional requirements.
• [Registration] Confirmatory studies should then be undertaken to provide the information necessary for handling, packaging, and labeling.
• [Registration] Depending on the extent of change special labeling or packaging may be needed to mitigate exposure to light.

Regulatory Requirements (ICH Q6A)

• [Marketing Approval] Osmolarity: When the tonicity of a product is declared in its labeling, appropriate control of its osmolarity should be performed.

Note: IND uses Investigator's Brochure instead

Source: 21 CFR 201.56; 21 CFR 201.57