Correction: FDA Issues Federal Register Notice: Prescription Drug Use Related Software

Date Correction: FDA encourages stakeholders to provide comments to the docket "Prescription Drug-Use-Related Software"(Docket No. FDA-2018-N-3017). The docket will be open until January 19, 2019.  

Today the FDA issued a Federal Register Notice “Prescription Drug Use Related Software” to announce the establishment of a docket to solicit public comment on the Agency’s proposed framework for regulating software applications disseminated by or on behalf of drug sponsors for use with one or more of their prescription drug products. For the purposes of this proposed framework, prescription drug-use-related software refers to software disseminated by or on behalf of a sponsor that accompanies one or more of the sponsor’s prescription drugs.  Software that is developed for use with prescription drugs but is not disseminated by or on behalf of a drug sponsor is not addressed in this proposal. Under the proposed framework, the output of such software, which includes material presented to an end user, such as a patient, caregiver, or health care professional, generally would be regulated as drug labeling. This proposed framework takes into consideration existing Agency policy for the regulation of software and is intended to align with ongoing Agency initiatives and foster innovation while ensuring sponsors' communications are consistent with applicable prescription drug labeling requirements. This notice is not intended to communicate FDA's proposed (or final) regulatory expectations but is instead meant to seek early input from groups and individuals outside the Agency prior to development of a draft guidance.

The notice outlines FDA’s proposed framework for oversight of prescription drug-use-related software output, including distinguishing when information about the output may be included in FDA-required labeling and when the output would be considered promotional labeling, as well as the Agency’s expectations for submissions of each type of labeling. The notice also contains specific questions about the proposed framework for stakeholders to consider.

FDA encourages stakeholders to provide comments to the docket  (Docket No. FDA-2018-N-3017). The docket will be open until January 19, 2019.  

For more information, please visit: FDA In Brief.