CLINICAL PHARMACOLOGY SECTION OF LABELING FOR HUMAN PRESCRIPTION DRUG AND BIOLOGICAL PRODUCTS — CONTENT AND FORMAT
On December 2nd, the FDA published a guidance intended to assist applicants in preparing the clinical pharmacology section of prescription drug labeling to meet regulatory requirements and ensure appropriate consistency in the format and content. Optimal pharmacotherapy is driven by an understanding of a drug’s clinical pharmacology and the clinical context in which the drug will be used. Important clinical pharmacology attributes to consider in therapeutic decision making include, but are not limited to, drug mechanism of action, pharmacodynamics (e.g., both on-target and off-target pathways), and pharmacokinetics in a variety of settings and specific populations. The new FDA guidance will help sponsors present the required information in a consistent and concise manner to help physicians in their clinical decision making across a range of patient sub-groups.