Dear Colleagues,
What are the regulatory reporting requirements for placing a QR code on drug packaging linked to information on the drug product via a mobile app?
- May the change made to the drug package label to incorporate the QR code be submitted in an Applicant's annual report in accordance with 21 CFR 314.70(d)?
- Is the information linked to the QR code subject to review by the Office of Prescription Drug Promotion?
Thank you for your assistance.
------------------------------
David Lucking
Coral Gables FL
United States
------------------------------