[PDF] Important Safety and Product Information Important Safety and

What should be included in a safety specification?

• The safety specification should identify risks believed to be common to the pharmacological class. B. Summary (2.2) At the end of the safety specification, a summary should be provided of the: • Important identified risks • Important potential risks • Important missing information

What is the guidance for drug safety?

• The guidance describes a method for summarizing the important identified risks of a drug, important potential risks, and important missing information, including the potentially at-risk populations and situations where the product is likely to be used that have not been studied preapproval.

What should the title of a product cover say?

• The title should make the purpose of the document obvious. Where appropriate, the title or other cover information should convey that it contains important safety information. This may be especially important where consumers feel they already are familiar with the product.

What should not appear on a safety label?

• Warnings for specific hazards can point to the instructions for full information. However, you should be careful to avoid mixing general instructions with warnings. Information that is not directly related to safety should not appear within safety labels. See Section 6, Presenting Safety Information, for more on the design of safety information.