FDA finalizes guidance on prescription drug use-related software
Industry welcomed the final policy, which governs app-based tools that manufacturers pair with drug products.
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By Daniel Okafor · Regulatory Correspondent
Oct 22 09:17 ETSource: STAT
The wire
- 01The FDA has finalized its guidance covering prescription drug use-related software, with pharmaceutical companies reacting favorably, STAT reports.
- 02Companion apps are increasingly bundled with injectable and oral peptide therapies, so the rules shape how sponsors label and promote those digital tools.
- 03The same STAT briefing flags telehealth marketing of GLP-1s for addiction; the guidance's practical effect on existing drug-app pairings remains to be seen.
From the source
Read at statnews.comSTAT+: FDA finalizes its guidance on apps related to drugs, pharma rejoices
In this edition of STAT Health Tech: FDA's guidance on prescription drug use-related software, and telehealth pushing GLP-1s for addiction.
