FDA’s Final Guidance for Drug Use-Related Software: A Win for the Pharma Industry?
FDA’s Final Guidance for Drug Use-Related Software: A Win for the Pharma Industry?
On October 20, 2026, the Food and Drug Administration (FDA) finalized its industry guidance around drug labeling for prescription drug use-related software (PDURS). The goal is to give sponsors a coherent framework for how use of an app with a prescription drug or device should be presented. Depending on what kind of app it is and whether it hooks up to a clinical outcome, it can either be considered FDA-required labeling, or promotional labeling.
Required vs. Promotional Labeling: A Quick Refresher
Anyone in the pharma space knows the rules around FDA-required labeling vs. promotional labeling, but here’s a little refresher anyway. FDA-required labeling is what’s reviewed and approved by the FDA as part of an NDA, ANDA, or BLA. The prescribing information (PI) is FDA-required labeling. Promotional labeling is everything else—stuff that’s disseminated with fair balance.
What Changed from the 2023 Draft
As connected devices and app use cases become more widespread in pharma, the industry hasbeen wondering how to represent use of software or apps in conjunction with prescription drugs in a compliant way, so this guidance from FDA (which was fairly clear, in my opinion) should be timely. Draft guidance on the subject was issued on September 19th of 2023, but the Agency has been working with sponsors and incorporating comments they received to make the final guidance more helpful. The decision tree and illustrative examples of PI language in the guidance are especially welcome additions to the draft guidance.
The final version also clarifies considerations for standalone software functions, recommends specific PI language for device-connected software that hasn’t shown a meaningful improvement in a clinical outcome, and swaps the term “digital health technologies” for “software with prescription drugs.”
The Deciding Question: Essential or Clinically Meaningful, or Neither of Those Things?
The crux of the issue, according to the guidance, is whether or not the function of the software (which is an app in both illustrative examples) is a) “essential to the safe and effective use of the product” or b) contributes to any meaningful clinical outcomes. If it’s essential to using the product, it needs to go in FDA-required labeling. If it’s associated with a meaningful clinical outcome in a well-controlled study, it needs to go in FDA-required labeling. That falls outside of promotional labeling (and thus outside of our purview as an ad agency, although it’s still something we need to be familiar with in use of the PI as a source for other promotional labeling).
If neither of those things is true of the app/software, there are options about what drug and device manufacturers can do. I won’t go into what the options are, because I think the decision tree in the guidance does a really great job of showing that process. Instead, I want to talk a little bit about my takeaways from reading the guidance.
An Open and Receptive Attitude from FDA = Opportunities
It was obvious from reading the guidance that the Agency is receptive to the use of apps in therapeutic settings.
As background, they noted the following: “FDA recognizes that the use of software with prescription drugs has the potential to offer new opportunities for patient care, and the Agency is working to promote responsible, risk-based oversight of such software.”
That’s a positive opener, and it stays positive throughout.
More than once, the guidance cites that information about an associated app is valuable for a physician when prescribing a product. It’s posed as something that could heavily factor into a physician’s risk vs. benefit analysis. A drug having an app is a potential benefit, according to the guidance, over drugs that may not have them.
With the provision of guidance for software applications that are both essential and non-essential, connected to clinical outcomes and not connected to clinical outcomes, the agency is opening the door for the industry to develop these kinds of resources confidently, backed by a predictable framework. To me, it seems like the FDA is actively inviting innovation from the industry in how apps are leveraged to assist patients while using a prescription drug or device.
What This Means for Pharma Marketers
As a pharma advertising agency, we’re excited to see that apps without a clinical benefit attached are still able to be governed under promotional labeling, and that they may warrant inclusion in the PI in some cases. Availability of an app that assists the end user can help with positioning a drug against competitors in the market, and the inverse is also true. As more manufacturers incorporate apps with prescription drugs or devices, those who don’t may be on the wrong side of that equation.
Keeping up with FDA guidance is something we’re committed to, and this was a pleasant piece of finalized guidance that we believe should open more avenues for companies considering whether to incorporate an app into their brand strategy.
If you’re looking for a grounded agency partner with the regulatory chops to keep you from rolling your eyes at our ideas but the creativity to surprise you anyway, give bfw a shout.
On October 20, 2026, the Food and Drug Administration (FDA) finalized its industry guidance around drug labeling for prescription drug use-related software (PDURS). The goal is to give sponsors a coherent framework for how use of an app with a prescription drug or device should be presented. Depending on what kind of app it is and whether it hooks up to a clinical outcome, it can either be considered FDA-required labeling, or promotional labeling.
Required vs. Promotional Labeling: A Quick Refresher
Anyone in the pharma space knows the rules around FDA-required labeling vs. promotional labeling, but here’s a little refresher anyway. FDA-required labeling is what’s reviewed and approved by the FDA as part of an NDA, ANDA, or BLA. The prescribing information (PI) is FDA-required labeling. Promotional labeling is everything else—stuff that’s disseminated with fair balance.
What Changed from the 2023 Draft
As connected devices and app use cases become more widespread in pharma, the industry hasbeen wondering how to represent use of software or apps in conjunction with prescription drugs in a compliant way, so this guidance from FDA (which was fairly clear, in my opinion) should be timely. Draft guidance on the subject was issued on September 19th of 2023, but the Agency has been working with sponsors and incorporating comments they received to make the final guidance more helpful. The decision tree and illustrative examples of PI language in the guidance are especially welcome additions to the draft guidance.
The final version also clarifies considerations for standalone software functions, recommends specific PI language for device-connected software that hasn’t shown a meaningful improvement in a clinical outcome, and swaps the term “digital health technologies” for “software with prescription drugs.”
The Deciding Question: Essential or Clinically Meaningful, or Neither of Those Things?
The crux of the issue, according to the guidance, is whether or not the function of the software (which is an app in both illustrative examples) is a) “essential to the safe and effective use of the product” or b) contributes to any meaningful clinical outcomes. If it’s essential to using the product, it needs to go in FDA-required labeling. If it’s associated with a meaningful clinical outcome in a well-controlled study, it needs to go in FDA-required labeling. That falls outside of promotional labeling (and thus outside of our purview as an ad agency, although it’s still something we need to be familiar with in use of the PI as a source for other promotional labeling).
If neither of those things is true of the app/software, there are options about what drug and device manufacturers can do. I won’t go into what the options are, because I think the decision tree in the guidance does a really great job of showing that process. Instead, I want to talk a little bit about my takeaways from reading the guidance.
An Open and Receptive Attitude from FDA = Opportunities
It was obvious from reading the guidance that the Agency is receptive to the use of apps in therapeutic settings.
As background, they noted the following: “FDA recognizes that the use of software with prescription drugs has the potential to offer new opportunities for patient care, and the Agency is working to promote responsible, risk-based oversight of such software.”
That’s a positive opener, and it stays positive throughout.
More than once, the guidance cites that information about an associated app is valuable for a physician when prescribing a product. It’s posed as something that could heavily factor into a physician’s risk vs. benefit analysis. A drug having an app is a potential benefit, according to the guidance, over drugs that may not have them.
With the provision of guidance for software applications that are both essential and non-essential, connected to clinical outcomes and not connected to clinical outcomes, the agency is opening the door for the industry to develop these kinds of resources confidently, backed by a predictable framework. To me, it seems like the FDA is actively inviting innovation from the industry in how apps are leveraged to assist patients while using a prescription drug or device.
What This Means for Pharma Marketers
As a pharma advertising agency, we’re excited to see that apps without a clinical benefit attached are still able to be governed under promotional labeling, and that they may warrant inclusion in the PI in some cases. Availability of an app that assists the end user can help with positioning a drug against competitors in the market, and the inverse is also true. As more manufacturers incorporate apps with prescription drugs or devices, those who don’t may be on the wrong side of that equation.
Keeping up with FDA guidance is something we’re committed to, and this was a pleasant piece of finalized guidance that we believe should open more avenues for companies considering whether to incorporate an app into their brand strategy.
If you’re looking for a grounded agency partner with the regulatory chops to keep you from rolling your eyes at our ideas but the creativity to surprise you anyway, give bfw a shout.
