Pharmaceutical Executive September 26, 2023
The agency differentiates between software that has a notable impact on the effectiveness and safety of drug use.
Pharmaceutical companies are embracing new technologies that could potentially assist patients with taking medication in a safe and effective manner.
In 2018, FDA began soliciting comments for a possible regulatory framework based around these technologies. In September 2023, the agency issued its draft guidance on the subject, explaining how drug sponsors should describe their software both in FDA required labeling and promotional labeling.
For the required labeling, which includes prescribing information, the sponsor can submit evidence to FDA that the software results in a meaningful improvement in a clinical outcome as compared to when the patient takes the drug without using the...
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