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FDA Webinar on Presenting Clinical Pharmacology Information in Prescription Drug Labeling

June 05, 2017

The Food and Drug Administration (FDA), Center for Drug Evaluation and Research Small Business and Industry Assistance (CDER SBIA) will host a webinar on June 19, 2017 titled “The Ins and Outs of Presenting Clinical Pharmacology Information in Prescription Drug Labeling.” Labeling and Health Communication staff from CDER’s Office of Clinical Pharmacology will present highlights from the FDA guidance Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products—Content and Format.

The Clinical Pharmacology section appears under Full Prescribing Information in the prescription drug labeling. This section should include both pertinent positive findings and important negative findings that will provide for safe and effective use of the drug or biological product. Information in the Clinical Pharmacology section can inform prescribing decisions. It includes mechanism of action, pharmacodynamics, and pharmacokinetics. It may also include information relating to microbiology and pharmacogenomics. In other relevant sections, clinical pharmacology information can support specific recommendations to health care providers. Examples include strategies for dosing, therapeutic individualization, and minimizing the risk of adverse reactions. The FDA guidance document attempts to define a format that is consistent, understandable, and useful to health care providers who may not have specific expertise in clinical pharmacology.

The goals of the webinar are to provide:

  • Key regulations that impact clinical pharmacology content in prescription drug labeling (also referred to as prescribing information or package insert (PI)).
  • Where clinical pharmacology content is found in prescription drug labeling.
  • The content structure of the Clinical Pharmacology section in prescription drug labeling.
  • Alternative methods of communicating complex clinical pharmacology content.

You will have an opportunity to submit questions upon registration and during a live Q&A session after the presentation.

Date: Monday, June 19, 2017
Time: 1:00 - 2:30 pm (Eastern)

Register for the event by clicking here.