Q.01

Has the FDA finalized its guidance on prescription drug companion apps?

Yes. FDA's guidance page now lists "Regulatory Considerations for Prescription Drug Use-Related Software" (the guidance that covers prescription drug companion apps) as a Final Level 1 Guidance, issued October 2026. The page says it "finalizes the draft guidance of the same title issued on September 19, 2023."

Approach: The datasets I can search don't include FDA's drug guidance catalogue, so I used FDA's guidance page and the Federal Register. I couldn't open the final guidance text itself, because the PDF link on the page returned an error.

What FDA's page shows (content current as of 10/20/2026):

  • Status: Final Level 1 Guidance; docket FDA-2023-D-2482.
  • Scope: It describes how FDA applies its drug labeling authorities to "certain software outputs that are disseminated by or on behalf of a drug sponsor for use with a prescription drug product or a prescription drug-led, drug-device combination product."
  • Issuing offices: CDER, CBER, CDRH, the Oncology Center of Excellence and Office of the Commissioner offices.
  • Comments: Comments can still be submitted at any time under 21 CFR 10.115(g)(5).

Background and timing:

  • FDA opened a public docket on prescription drug-use-related software in November 2018 and reopened its comment period in February 2019.
  • The draft guidance was announced in the Federal Register on September 19, 2023 (document 2023-20241).
  • I found no Federal Register notice yet announcing the final guidance. The newest Federal Register document on this topic is still the 2023 draft notice. FDA usually follows a final guidance with a notice of availability, so expect one to appear soon.
  • General web search summaries still describe the guidance as a draft. They are out of date compared with FDA's own page.

Because the final text couldn't be opened, I can't say what changed from the 2023 draft. I can try again and compare the final guidance with the draft if that would help.

Sources:

Q.02

When does app output count as labeling or promotion?

FDA treats all end-user output of prescription drug use-related software as prescription drug labeling. Whether it counts as labeling isn't the open question. The open question is whether a given output is FDA-required labeling or promotional labeling, and I couldn't open the guidance text where FDA sets out that test. So I can describe the framework, but I can't give you FDA's criteria or examples.

Approach: The datasets I can search don't hold this guidance; the FDA guidance collection I checked covers device-centre documents only. I then used FDA's guidance page and the Federal Register. The guidance file on FDA's page (media/172165) couldn't be read as text, and FDA's related briefing and presentation files returned errors.

What the official sources say

  • Which software is covered: software that "(1) is disseminated by or on behalf of a drug sponsor and (2) produces an end-user output that supplements, explains, or is otherwise textually related to one or more of the sponsor's drug products" (2023 Federal Register notice of the draft).

  • What "end-user output" means: "any material (content) that the prescription drug use-related software presents to the end user." FDA states it "considers end-user output a type of prescription drug labeling."

  • What the guidance decides: according to the notice, it explains:

    • how FDA applies its drug labeling authorities to end-user output;
    • "how FDA intends to treat certain prescription drug use-related software as FDA-required labeling";
    • "when and how sponsors should submit end-user output to FDA."

    The notice refers to the existing collections for drug applications (OMB 0910-0001) and Form FDA 2253, the form used to submit promotional materials. It does not say which outputs go down which route.

  • Status: FDA's guidance page (content current as of 10/20/2026) lists the final guidance, docket FDA-2023-D-2482. It now also links Federal Register document 2026-21516, which I couldn't open. In my last answer I said no notice for the final guidance had appeared yet; this link is newer than that.

What I couldn't confirm

  • FDA's test for when output is FDA-required rather than promotional labeling.
  • The examples FDA gives.
  • The submission route for each category.
  • Anything that changed between the 2023 draft and the October 2026 final.

Search-result summaries say most companion-app functions would be treated as promotional and submitted when first disseminated. I couldn't find that on any FDA page I opened, so I'm not relying on it.

If you can share the final guidance PDF, I can pull out the classification criteria and submission route for each type of output, and compare them with the draft.

Sources:

Q.03

When does it belong in the prescribing information?

Under the 2023 draft, what decides whether software appears in the prescribing information (PI) is whether the sponsor submits evidence that using the software leads to a clinically meaningful benefit. I couldn't read FDA's own text this time, so that comes from how the draft's sections are laid out, as reproduced in a public comment on FDA's docket. I can't give you FDA's wording, its evidence standard, or what the October 2026 final guidance changed.

Approach: The datasets I can search don't hold FDA's drug labeling guidance, so I went to FDA's guidance page, the Federal Register and the regulations.gov docket (FDA-2023-D-2482). The final guidance file now returns "not found" on FDA's site, and the Federal Register notice for the final (2026-21516) couldn't be opened.

What the draft's structure shows The Biotechnology Innovation Organization (BIO) filed a comment on the docket on December 18, 2023. It reproduces the draft guidance's section headings:

  • Section IV: "Describing Prescription Drug Use-Related Software Functions and End-User Output in the Prescribing Information"
    • A. "When the Drug Sponsor Submits Evidence Demonstrating That the Use of Prescription Drug Use-Related Software Leads to a Clinically Meaningful Benefit"
    • B. "When the Drug Sponsor Does Not Submit Evidence of a Clinically Meaningful Benefit"
    • C. "Additional Considerations Relating to Review of End-User Output"

BIO describes the evidence case as the one that "would allow the inclusion of its output in the PI." It also refers to evidence from an "adequate and well controlled study." Without such evidence, BIO reads the draft as treating the output as promotional labeling. BIO also names the two submission routes for changes that alter end-user output: a "PI change or Form 2253." These are BIO's readings of the draft, not FDA's statements.

A separate point for device-connected software BIO quotes the draft (lines 170-176): when the software takes input data from the device part of a combination product, FDA "intends to assess whether the combination product used with the software can accurately and reliably provide the data, perform analyses, and display the end-user output (regardless of whether the end-user output is FDA-required or promotional labeling)."

What the 2023 Federal Register notice adds Nothing on this point. It says only that the guidance explains "how FDA intends to treat certain prescription drug use-related software as FDA-required labeling." It never mentions the prescribing information.

What BIO said was still unclear in the draft (useful as a checklist when you read the final)

  • What kinds of clinical benefit count, whether linked to effectiveness or to safety.
  • Whether the PI would name the specific software used in the study, or only describe the output.
  • What wording is acceptable in the PI, for example QR codes or app download links.

Search-result summaries say FDA tells sponsors to talk to the review division early about the data that would support PI inclusion. I couldn't find that on any official page I opened, so I'm not relying on it.

If you can share the final guidance PDF, I'll pull out FDA's actual criteria for Section IV and compare them with the draft.

Sources:

Q.04