Are you developing a generic drug combination product and planning to submit it to the FDA using the Abbreviated New Drug Application (ANDA)? If so, you need to familiarize yourself with new ANDA Draft Guidance the FDA published in January 2017. You may be surprised by the FDA’s current thinking on ANDA submissions. We were!

The purpose of the ANDA Draft Guidance is to ensure that a generic combination product can be seamlessly substituted at the pharmacy for the brand-name product.

What Has Changed:

Generic drug manufacturers may now be required to begin Usability Testing with a Threshold Analysis. The Threshold Analysis is an internal audit that compares:

1. Brand-name drug labeling versus generic labeling (e.g., prescribing information, instructions for use, and packaging),

2. Physical attributes of the brand-name drug delivery device versus the generic drug delivery device

3. Tasks required to administer the brand-name drug versus the generic drug.

If threshold analysis reveals only minor differences between the brand-name and generic drug delivery devices, and no additional risks are associated with the generic drug delivery device, then usability testing with end users may not be required.

However, if there are noticeable differences or increased usage risks, then a Comparative Usability Study needs to be conducted with both patients and caregivers. The FDA Guidance for Comparative Usability Studies requires a quantitative sample size of 50 to 155 users, ideally experienced users of the name-brand drug. Error rates are then compared for usage of the brand-name and generic drugs. If the generic achieves an equivalent error rate to the name-brand product, it may be approved by the FDA without further Usability Testing, shortening the regulatory cycle.


Generic drug manufacturers may have an opportunity to decrease the amount of time and money spent on Usability Testing by closely following the original name-brand device specifications and using an ANDA. If your team has questions about how this will impact current product development, please give us a call. To read the complete Draft Guidance, follow this LINK.

Metaphase Design Group has been conducting global usability studies on drug delivery devices for 20+ years, working with numerous industry leaders including: BD, Biogen Idec, Bayer, Bristol Myers Squib, Genentech, and Amgen.

We provide a full range of services for conducting ANDA Analyses and FDA Usability Studies, from defining the best research methodologies to managing IRB applications through to developing insightful finished reports for FDA submissions and Design History Files. If you need help or would like to brainstorm the best way to approach your current project, call or email.