Drugs

Combination Product Labeling Contents

The Combination Products Coalition says it has some concerns and suggestions for improvement in a draft FDA guidance on instructions for use (IFU) in patient labeling for combination products. The coalition’s comment letter recommends that the agency revise the document to:

clarify that the final layout and content of an IFU should be based on outcomes of the human factors process and the expertise of instructional design professionals, and that the content and layout proposed in the draft are suggested but not required;
provide clearer guidance on criteria by which a manufacturer decides whether a product requires an IFU;
clarify the draft guidance scope; and
provide additional guidance on how and when IFUs are to be submitted for review.

The American Academy of Orthopedic Surgeons (AAOS) says it agrees with the agency recommendations for content and formatting of the label. “In addition to incorporating easily understandable language,” it says, “the inclusion of a visual display will further support the use of the instructions by patients with low literacy levels…. Safe storage and disposal information is a critical element of the patient label, and the AAOS strongly encourages industry to immediately implement these recommendations.”

Finally, GlaxoSmithKline says the guidance appears to focus recommendations primarily on the content and format of the text version of the IFU that accompanies prescriber and patient labeling rather than the artwork version on which the text is based. “As the two versions are related in content and graphics, but not necessarily in format or layout,” the letter says, “it would be helpful for the agency to clarify the intent of this guidance and how it applies to both elements of draft labeling, particularly as the artwork version involving human factors testing and consult with CDRH undergoes development ahead of the Word/SPL version submitted with draft prescribing information.”

All three comment letters include specific line-by-line comments

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