Drug safety- FDA concern about black box warning

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Dear Members,

Summary of Selected Methods for FDA Communication of Drug Safety Information

Type of Communication

Content

Target Audience

Professional labeling for prescription drugs

Summary of essential information needed for safe and effective use of the drug.

Healthcare providers

Patient-directed labeling for prescription drugs (patient package inserts and Medication Guides)

Summary of essential information needed for safe and effective use of the drug.

Patients

OTC “Drug Facts†labeling

Summary of essential information needed for safe and effective use of the drug.

Consumers

Public Health Advisory

Information and advice regarding an emerging drug safety issue or other important public health information.

General public

Patient Information Sheet

Concise summary in plain language of the most important information about a particular drug. Includes an Alert when appropriate to communicate an important, and often emerging, drug safety issue.

Patients and/or consumers, lay caregivers, and interested members of the general public

Healthcare Professional Sheet

Concise summary of an important, and often emerging, drug safety issue, with background information about the detection of the issue and points to consider for clinical decision making.

Healthcare professionals

Alerts on Patient Information and Healthcare Professional Sheets

Summary of an important, and often emerging, drug safety issue. Alerts are tailored to the needs of the primary target audience for each type of information sheet.

Healthcare professionals, patients and/or consumers, lay caregivers, and interested members of the general public

Tarun Wadhwa