FDA finalizes instructions for use guidance for drugs, biologics

Regulatory NewsRegulatory News | 14 July 2022 |  By 

The US 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 complicated instructions for using a drug or a biologic.
The guidance covers human prescription drug and biological products, as well as drug-led or biologic-led combination products submitted under a new drug application (NDA) or a biologics license application (BLA). It specifies that “the IFU is written for patients (or their caregivers) who use drug products that have complicated or detailed patient-use instructions.”
The final version makes minor changes from the draft version that was released for comment in 2019. (RELATED: FDA drafts two new guidances on drug labeling, Regulatory Focus 1 July 2019)

Revisions include a more comprehensive discussion in footnote 6 on the role of human factors to inform he 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“Rather than excluding HF considerations from the scope of the draft guidance ... the CPC believes that the draft guidance should allow for more supportive HF data to support IFU content or design that may vary or depart from the recommendations made in the draft guidance,” CPC wrote in its public comment.
The final version also adds language on labeling for drugs for self-administration. The text states, “For drugs for which self-administration may be complicated (such as requiring the patient to perform multiple steps to prepare, administer, store, and/or dispose the drug), the IFU is intended to give directions that are clear and understandable for patients, and therefore, promote the safe and effective use of that drug.”
The final version also adds text in the “additional information” section stating that labeling should include a phone number for reporting problems with products, and for reporting adverse reactions.
Additionally, it includes language advising applicants to meet with FDA during the investigational new drug (IND) phase to discuss the development of the IFU.
FDA also clarifies that the guidance does not apply to stand-alone devices regulated under a BLA, such as devices associated with blood collection and processing procedures. The change was made at the request of the Pharmaceutical Research and Manufacturers of America (PhRMA).
Other changes include modifying the title and changing the scope of the guidance from drug-device combination products to drug-led combination products.
FDA’s final guidance on IFU labeling
Comments on draft guidance


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