Module 8
Populating the Warnings & Precautions
Section of a CCDS – Placement of information
on Use in Specific Populations
For the content of a Warnings section and those statements in a combined Warnings and Precautions section that are considered warnings, authors of CCDS should have threshold criteria for elevating the risk information and any associated advice to this high rank of visibility in labeling. These criteria should be carefully chosen, taking into account FDA's proposed significance criteria and labeling practice in other markets. Documenting these criteria and communicating them to affiliates can serve as a basis for rational modifications of this section's content to meet local labeling expectations.
When populating the Warnings and Precautions section of a CCDS (or separate Warnings and Precautions sections) it is often difficult to decide which precautions to include here, and which to include in other sections that can/could legitimately contain precautionary advice (such as the Dosage and Administration or Interactions sections). Placement rules for precautionary advice and robust principles (applicable to headquarters and affiliates) for limiting duplication of information and for cross-referencing can alleviate these problems.
With the FDA's move – for PI with Highlights – to a separate labeling section that bundles information on specific populations (possibly including, for example, patients with renal or hepatic impairment), CCDS authors should reevaluate their rules for placing this type of information. Business rules for the implementation of CCDS content may need to be adjusted if a company decides not to adopt a Use in Specific Populations section for the CCDS.
Curriculum topics of this module include:
- Split or combined Warnings and Precautions sections for CCDS – pros and cons
- Threshold criteria for elevating risks to the warnings level – relevance criteria and level of certainty
- Business rules for the processing of warnings into local labeling
- Subsection themes and subsection order
- Limiting information duplication and cross-referencing – Rules for CCDS, rules for local labeling, and business rules for implementation
- Information on the ability to drive and operate machinery – Should we have a separate section in the CCDS? Should we follow the EU rules for including such information?
- Information needed to choose a pregnancy category; FDA's concept paper on pregnancy labeling
- Creating a Use in Specific Populations section for core labeling – pros and cons