Draft Guidance Issued for Drug and Biologics Labeling

On Mar. 3, 2009, the US Food and Drug Administration released a draft guidance for Industry titled “Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products: Content and Format.” The draft is one in a series of guidance documents aimed at helping applicants comply with new FDA regulations (21 CFR 201.57 finalized January 2006) on the content and format of labeling for prescription drugs and biological products.

New FDA regulations require that the clinical pharmacology sections of the labeling contain the following subsections: mechanism of action, pharmacodynamics (PD), and pharmacokinetics (PK). The guidance is designed to make information in prescription-drug labeling easier for healthcare practitioners to access, read, and use.

The document states that the Clinical Pharmacology section “should include information on both positive findings and pertinent negative findings” as well as “information about the parent drug, active metabolites, and enantiomers that lead to the intended therapeutic effects or unintended effects (e.g., toxicities).” Intended or unintended effects resulting from additives should also be included in the labeling. The draft also states that “graphs and/or tables depicting PK attributes, exposure– or dose–response relationships, and/or PK/PD relationships can be helpful in simplifying or clarifying the labeling, and their use is encouraged.”

FDA will accept comments about the draft until June 1, 2009.

The Federal Register Notice is available here.

The draft guidance is available here.