Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products – Content and Format

Status: Final

Date: January 2006

Target Audience:

Applicants responsible for preparing the Clinical Studies section of a label

Laws Referenced:

  1. Title 21 of Code of Federal Regulations (21 CFR), Part 201.56
  2. 21 CFR 201.57
  3. 21 CFR 202.1

Rationale:

The FDA would like doctors (or prescribers) to be able to make informed decisions concerning the safe and effective use of a drug for their patients based on the information contained in the package insert. In addition, the FDA would prefer that a class of drugs would have similar organization and information in the Clinical Studies section of a label.

Summary:

This guidance serves as an instructional manual to help applicants decide what would be appropriate to include in the Clinical Studies section of a label.

Recommendations:

When considering what to include in the Clinical Studies section of a label, the guidance recommends the following:

  1. Include studies that describe how effective the drug is.
  2. Provide a description of the methods including the study design, who participated in the study (study population), and measures of effectiveness (endpoints). Did any of the subjects take concomitant medications while participating in the study?
  3. Include a description of the patient disposition characteristics (age, gender, race) and analysis results that are relevant to the study objective and endpoints. Do not include data that would not add any information.
  4. Use tables and graphs to display results. The appendix provides examples and suggestions.
  5. When summarizing the results, do not make claims that are not supported by the data. Avoid vague statements. The sponsor’s marketing section may extract information from the Clinical Studies section to create promotional material.
  6. Ensure information in this section is consistent with other labeling sections. For example, results in the Clinical Studies section should not be presenting new information that has not been previously introduced in other labeling sections, such as Indications and Usage.
  7. Update the Clinical Studies section when any of its content needs revision so that the information is valid.

Impact:

The suggestions for what content to include are consistent with the methods, results, and discussion format for scientific writing. Although the recommended structure may be helpful to physicians, it would seem that the important piece in the guidance is following scientific principles in presenting claims of effectiveness that are supported by data.

For more information on this issue, contact the Kulkarni Law Firm.