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The Clinical Pharmacology section of labeling for prescription drugs and biological products, one of many that must be included in a drug or biologic’s Full Prescribing Information, should contain “information that is important for safe and effective use of the drug,” states the FDA in 21 CFR 201.57 and its draft guidance. This information should be written for practitioners who may not be well-versed in clinical pharmacology. Before taking a closer look at the actual wording with which the FDA encourages the use of graphics and tables in the Clinical Pharmacology section, note that this is a draft guidance and that even a finalized version reflects suggestions and recommendations, not requirements.
Section II. Clinical Pharmacology Section, Part F. Use of Pharmacokinetic, Dose-Response, and/or PK/PD Graphs and Tables, contains a small but important piece of information:
Graphs and/or tables depicting Pharmacokinetic (PK) attributes, exposure- or
dose-response relationships, and/or PK/PD [Pharmacodynamics] relationships can
be helpful in simplifying and/or clarifying the labeling and their use is
encouraged. When graphs or tables are used, variability measures should be
included.
The above is the entire section lifted directly from the guidance. The use of graphs and tables should give labels for new drugs quite a facelift, while also educating practitioners to make more informed decisions, based on statistics. Manufacturers already have this information in their promotional materials, so transferring it to their Package Inserts should not be costly. However, manufacturers must be sure to represent this data accurately, and not to manipulate the numbers through their graphs and tables.
For more information, see the draft guidance in its entirety. If you have specific questions, contact information for the appropriate CBER/CDER representatives is provided on page 1 of the guidance.
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