How to Create FDA Acceptable IFU: New Guidance
(Thursday, July 21, 2022)
The Instructions for Use (IFU) provide critical information on how to use or administer a drug or biologic product for a patient or caregiver. FDA expects the IFU to be written in a simple non-technical language, in active voice, with size 10 or above font preferably Arial or Verdana, avoiding shading or highlights and many other nuances. All these are listed in great details in the later Guidance Document released this week. The IFUs are needed in addition to the Package Insert (PI) for drugs and biologics with complicated administration or dosing processes. While the PIs are intended for the physicians and medically trained professionals, the IFU is intended for the patients, hence the need to simply the instructions to avoid accidental misuse. The IFU guidance is applicable to prescription drugs and biologics, but the principles described can be applied to over-the-counter drugs and other products. There are many concerns with the readability, accuracy, comprehension, and compliance that must be addressed in an IFU. The guidance lists all the issues that require clear guidelines in terms of creating a compliant IFU. Seemingly mundane issues such as the type and size of font, use of images or line drawings, use of abbreviations and acronyms, use of capital letters are discussed along with medical information such as description of dose, dosing regimen, risk statements, step-wide directions, storage, and disposal. Human Factor evaluation is also suggested. The guidance also includes a template or checklist of sorts for creation of the IFU. This is an essential read for practically all NDA and BLA applicants which require complicated use instructions.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC