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US FDA Guidance On Patient Labeling Leaves Unanswered Questions For Combination Products

 
• By Brenda Sandburg

Final guidance does not address recommendations raised by PhRMA and others about product descriptions and incorporating human outcome factors in instructions for use.

Drug instructions for use
FDA guidance describes what to include in instructions for use of prescription drug products • Source: Shutterstock

The US Food and Drug Administration’s final guidance on patient instructions for use of drug and biological products does not include details sought by industry, including clarity on the identification of drug products with multiple parts and the human factors that may impact instructions.

The guidance, “Instructions for Use – Patient Labeling for Human Prescription Drug and Biological Products – Content and Format,”...

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