FDA Finalizes Guidance on Labeling

December 2016

The US Food and Drug Administration (FDA) on Friday finalized its guidance for completing the clinical pharmacology section for drug, generic drug and biologic labels.

Specifically, the guidance includes detailed descriptions of the data required for the clinical pharmacology section of the labeling for drugs, biologics and generics for new submissions, as well as amendments to a product's labeling.

FDA first released the draft version of the guidance in 2009 in order to meet the goals established in its 2006 Physicial Labeling Rule (PLR). However, in 2014, FDA released a revised version of the draft guidance in response to calls for the agency to clarify the information that should be included and how to use headings and subheadings in the section.

While the final version of the guidance is largely similar to the revised draft version and follows the same format, the document has been largely re-written and includes several new paragraphs to clarify certain aspects of the guidance.

For instance, under the section on information to be included in each clinical pharmacology subsection (Section 12), FDA has added clarification that companies should express dosages outside the approved recommended dosage range as a proportion of the highest and lowest dosages. For example: "50 milligrams (mg) (0.5 times the lowest approved recommended dosage) to 400mg (2 times the highest approved recommended dosage)" assuming the approved recommended dosages are 100mg and 200mg"

Additionally, under Subsection 2.1 Mechanism of Action (MOA), FDA has added clarification that companies should not include information on the MOA for indications or uses not included in the product's indication. "Speculative claims of untested MOAs unsupported suggestions of therapeutic advantages based on MOA may be false or misleading and, therefore, must be avoided," FDA writes.

FDA also includes a new section at the end of the guidance that clarifies that companies do not need to submit a labeling supplement "solely to address a minor formatting change (e.g., modifying or re-ordering heading or subsection titles) referred to in this guidance document that is not a regulatory requirement or a safety issue."

Any minor formatting changes, FDA says, should be documented and included in the product's next annual report. www.raps.org