FDA Finalizes Guidance on Clinical Pharmacology Product Labeling

The FDA finalized its guidance for applicants on meeting regulatory requirements related to the content and formatting of the clinical pharmacology section of a proposed product label.

The clinical pharmacology section must contain at least three subsections: mechanism of action, pharmacodynamics and pharmacokinetics. Two additional headings, microbiology and pharmacogenomics should be used when appropriate. The agency’s final version is largely unchanged from a 2014 draft guidance.

The first section should discuss the drug’s mechanism of action at cellular, receptor and membrane levels, as well as in tissues, organs and the body as a whole. Antimicrobial mechanisms of action should be described in the fourth subsection, microbiology.