Regulatory news| July 14, 2022 | By
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The U.S. Food and Drug Administration (FDA) on Thursday finalized guidance on the content and format of instructions for use (IFU) labeling for pharmaceutical manufacturers to help consumers understand the complicated instructions for using a drug or biological product.
The guidelines cover prescription drugs and biologics for human use, as well as drug-based or biologic-based combination products submitted as part of a New Drug Application (NDA) or a biological product license (BLA). It clarifies that “the instructions for use are written for patients (or their carers) who use medicinal products that have complicated or detailed instructions for use for the patient”.
The final version makes minor changes from the draft version that was released for comment in 2019. (RELATED: FDA drafts two new drug labeling guidelines, Regulatory guidance July 1, 2019)
The revisions include a fuller discussion in footnote 6 on the role of human factors in informing the development of an IFU. The change was made at the request of the Combination Product Coalition (CPC).
“Rather than excluding HF considerations from the scope of the Draft Guidelines…the CPC believes that the Draft Guidelines should allow for more useful HF data to support IFU content or design which may vary or s ‘deviate from the recommendations made in the draft guidelines,’” CPC wrote in its public comment.
The final version also adds language on the labeling of drugs intended for self-administration. The text reads: “For drugs where self-administration may be complicated (such as requiring the patient to perform multiple steps to prepare, administer, store and/or dispose of the drug), the IFU is intended to provide clear instructions. and understandable to patients, and thus promote the safe and effective use of this medicine.
The final version also adds text in the “additional information” section indicating that the labeling must include a telephone number to report problems with the products and to report adverse reactions.
Additionally, it includes language advising applicants to meet with the FDA during the Investigational New Drug (IND) phase to discuss IFU development.
The FDA also clarifies that the guidelines do not apply to stand-alone devices regulated by a BLA, such as devices associated with blood collection and processing procedures. The change was made at the request of Pharmaceutical Research and Manufacturers of America (PhRMA).
Other changes include changing the title and changing the scope of the guidance from combination drug-device products to combination drug-based products.
Final FDA Guidelines on IFU Labeling
Comments on the draft guidelines
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