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 To avoid such adversities, the United States Food and Drug Administration (US FDA) has released a draft guidance of Indications and Usage section of labeling for human prescription drug and biological products on 3rd July 2018.

This guidance for labeling is released/published, primarily, to aid sponsors to comply with final rule on prescription drug and biologics labeling. The aim of 2006 final rule is to assist healthcare practitioners in identifying appropriate therapies for patients by clearly communicating the drug’s approved indications.

What is Indications and Usage Section of Labeling for?

The main objective of indications and usage section is to inform the 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.

To add the above requisites to the product label and to comply with FDA’s CFR 201.56 and 201.57 regulations, the indication and usage section’s content must:

  • 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 of information irrelevant to indications and usage. Even when necessary for further explanation, they must be in brief and then cross-referenced to the relevant section of labeling for detailed explanation.
  • 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.

Content and format of the Indications and Usage section:

Before drafting the section’s content, applicants may have to decide on 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 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

The principles and considerations discussed above are just a tip of an iceberg. A comprehensive overview of the FDA guidance will be helpful to achieve compliance on time.  As the guidance yet to be finalized, consider decoding it with the aid of a Regulatory labeling expert. Keep a check over the non-compliance and reworks. Act on time. Be compliant.


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