Indications and Usage Section of Labeling

Lack of clarity on indications and uninformed usage of drugs and biological products may lead to unforeseen adversities, which might in turn affect manufacturers / sponsors through financial penalties and legal actions. To avoid such adversities, the United States Food and Drug Administration (US FDA) has released a draft guidance of 'Indications and Usage' section of labeling for human prescription drug and biological products on 3^rd July 2018. In today’s Regulatory ecosystem, with increasing focus on risk mitigation and real-world evidence, the accuracy of the Indications and Usage section continues to be a critical component of Regulatory labeling compliance, global labeling governance, and Regulatory submission quality.

This guidance for labeling aids sponsors in complying with the final rule on prescription drug and biologics labeling. The 2006 final rule assists healthcare practitioners in identifying appropriate therapies for patients by clearly communicating the drug’s approved indications. With evolving FDA expectations and increased scrutiny in labeling audits, organizations are now integrating digital labeling systems, structured content authoring, and automated labeling workflows to ensure consistency in Indications and Usage statements across product families and global markets.

What is the 'Indications and Usage' Section of Labeling for?

The main objective of the 'indications and usage' section is to inform about safety and to minimize the occurrence of such events. It can be achieved by presenting clear, concise, and consistent indications by stating disease/condition/manifestation/symptom for which the drug can be used to treat/prevent/mitigate/cure/diagnose. This section plays a pivotal role in reducing misinterpretation, supporting Regulatory data integrity, and maintaining label content accuracy across the product lifecycle.

• Reflect scientific evidence accurately
• Be concisely written to include the information necessary to clearly convey the uses for which the drug has been shown to be safe and effective
• Include terminology that is clinically relevant and scientifically valid, and understandable to healthcare practitioners

To adhere to the FDA’s content specifications, the applicants may consider the following principles while compiling the Indications and Usage section.

• Scope of indication: All indications for drugs and biological products and other statements mentioned in the section must be supported by substantial evidence of effectiveness based on studies. Indications or uses must not be implied or suggested in other sections of the labeling, if not included in the Indications and Usage section.  However, if the drug is commonly prescribed for a disease or condition which may be associated with significant risks or hazards, the FDA may require a specific warning relating to an unapproved use in the “Warning and Precautions” section of the labeling. Scope listed below must be considered:
  • Scope of indication relative to population studied
  • Age groups in indication
• Distribution of information among labeling sections: The section must not comprise information irrelevant to indications and usage. Even when necessary for further explanation, they must be brief and then cross-referenced to the relevant section of labeling for detailed explanation. Maintaining clear separation of content aligns with modern label architecture best practices and ensures high standards of Regulatory document control.
• Updating the Indications and Usage section: All information that is part of Indications and Usage section must be updated duly when new information about the drug, drug class, or specific disease becomes available that makes the labeling inaccurate, false or misleading. It is also recommended for applicants to draft the section to reflect current practices for writing indications for the drug / biological product.

With frequent updates from global health authorities, companies increasingly rely on label change management systems, CCDS-to-LPD alignment strategies, and Regulatory intelligence monitoring to ensure that this section remains accurate and globally harmonized.

Content and format of the Indications and Usage section:

Before drafting the Section’s content, applicants may have to decide the conceptual depth of the information added, which shall keep the users and physicians informed. Moreover, they may also check that additional information, such as identification of the disease or the condition provided to support indications, is validated and accepted by the FDA. Components of the Section’s information mentioned below must be drafted with due consideration towards the suggested content and format.

• Indication: The indication must begin with “Drug-X is indicated” and must include:
  • The disease, condition, or manifestation of the disease or condition
  • When applicable, other information necessary to describe the approved indication
• Limitations of use: Usage limitation information must be included in the Indications and Usage section only if knowing such information helps the practitioners to ensure safe and effective use of drug
• Other considerations for writing the Indications and Usage section:
  • Identification of outcomes, endpoints, and benefits, the drug conveys
  • Accelerated approval
  • Required or recommended language
  • Preferred wording and wording generally to avoid
• Formatting the Indications and Usage section:
  • Format for multiple indications
  • Format for limitations of use

In the current digital-first labeling environment, adopting structured templates, controlled vocabularies, and standardized label authoring practices helps reduce inconsistencies and ensures high-quality Regulatory submissions.

As labeling expectations evolve globally, partnering with a leading Regulatory labeling services provider can help streamline Regulatory content management, label lifecycle governance and audit-ready documentation, ensuring long-term compliance and reduced operational risk. Contact our experts at Freyr for labeling compliance.