FDA Guidance on Clinical Pharmacology Section of Drug and Biological Product Labeling

• By: Staff Editor
• Date: January 30, 2017
• Source: http://www.fda.gov

FDA Guidance on Clinical Pharmacology Section of Drug and Biological Product Labeling

The clinical pharmacology section of the label should provide an information that is understandable and clear to health care professionals who may not have specific expertise in clinical pharmacology. The FDA guidance offers recommendations for preparing the clinical pharmacology section of prescription drug labeling for applicants submitting NDAs, supplements to approved NDAs, ANDAs, biologics license applications (BLAs) and supplements to BLAs.

Clinical Pharmacology Section Information

This section of labeling must contain the following subsections:

Mechanism of Action (MOA):

It should summarize the MOA at various levels including the cellular, receptor, or membrane level, tissue, the physiologic system level, and the whole body level.

Pharmacodynamics:

This subsection should provide an overview of biochemical, physiological or pharmacological effect of the drug or its active metabolites related to the drug’s clinical effect or adverse effects.

Pharmacokinetics:

It should include a brief introduction about the significant pharmacokinetic properties including absorption, distribution, elimination, specific populations, and drug interaction studies of the parent drug and its relevant metabolites.

Microbiology:

This part should cover the information pertinent to the microbiology characteristics of the drug.

Pharmacogenomics:

Clinically relevant information on the effect of genetic variations affecting drug therapy should be included under this section.

In addition, the guidance also provides information on presentation format of the qualitative and quantitative data in the clinical pharmacology section of labeling.

Related Training:

Meeting FDA Requirements for OTC Drug Labeling

FDA Regulations for Marketing and Labeling OTC Drugs in the U.S.