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Draft FDA Labeling Guidance Proposes More Clarity for Providers

The FDA's draft guidance on labeling for prescription drugs and biologics focuses on giving healthcare practitioners clear and precise information that they can understand.

The draft, titled Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format, is to replace the original guidance of the same name published in 2010. The agency released the draft in January and withdrew the 2010 guidance of the same name. A public comment window for the revised draft closes March 14.

The FDA published the original guidance to direct drugmakers on the best ways to format information on labels for pharmaceutical and biopharmaceutical products. Since then, the biologics space has exploded with activity, so it makes sense that the agency would revisit its labeling standards and provide more clarity on its expectations for prioritizing information and organizing it with headings, subsections, tables, and cross-references to other sections. In the draft guidance, FDA provides more examples of dos and don’ts that have become more relevant since the first version.

In general, the FDA recommends not cluttering up the section with information considered to be general medical knowledge or broad information that does not specifically pertain to the drug being considered. This is because such statements serve as a distraction from the critical information that is actually recommended on the label.

The draft guidance breaks down FDA’s content recommendations as displayed in Figure 1.

Figure 1. Content Sections of January 2023 Draft Guidance, Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products

For access to the full article, please visit: Pharmaceutical Online.

Let us know what you think. Did you get your comments into the FDA by the deadline?


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