FDA Risk Communication (entry level + intermediate)

FDA Risk Communication (entry level + intermediate)

$125.00

Detailed review of HOW TO COMMUNICATE RISK INFORMATION, including the definition and execution of fair balance in promotional materials. Common terms will be defined and illustrated, including Brief Summary, Boxed Warning, Important Safety Information (ISI) and Adverse event (AE) reporting. Examples of enforcement letters will illustrate the application of these requirements.

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