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Regulatory Focus™ > News Articles > FDA Offers Recommendations on Highlights Section of Labeling

FDA Offers Recommendations on Highlights Section of Labeling

Posted 18 January 2018 | By Michael Mezher 

FDA Offers Recommendations on Highlights Section of Labeling

The US Food and Drug Administration (FDA) on Thursday issued draft guidance providing recommendations on completing certain portions of the Highlights section of labeling for prescription drugs and biologics.

Specifically, the guidance details the content and format of the Product Title and Initial US Approval subsections within the Highlights of Prescribing Information for newly approved drugs and drugs with labels being revised.

In 2006, FDA's final rule on the content and formatting of labeling for human drugs and biologics, also known as the physician labeling rule (PLR), required prescription labeling to contain three sections: Highlights of Prescribing Information, a Table of Contents and Full Prescribing Information.

The Highlights section was developed specifically with physicians and healthcare providers in mind and contains the most important and commonly referenced information within the labeling.

While FDA's guidance on the PLR describes the requirements for what should be included in the Highlights section, the new draft guidance provides greater detail and examples for each specific item in the Product Title and Initial US Approval subsections.

As such, FDA says the new guidance will "bring greater consistency to the presentation of these required elements in labeling and to help ensure these elements provide clear and useful information to the reader."

The guidance also includes recommendations for products with special nomenclature considerations, what not to include in the product title section, and discusses implications for container and carton labeling.

Federal Register Notice, Draft Guidance

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