FDA issues final guidance on drug-related mobile applications

The FDA has released its final guidance addressing software applications that are used in connection with prescription drugs.

The guidance clarifies how the agency will evaluate and regulate apps that provide drug information, dosage assistance, or other therapeutic functions, aiming to ensure safety and effectiveness.

Companies developing digital therapeutics will need to align their products with the new criteria, which may affect development timelines and regulatory submissions.

The announcement was part of a broader focus on health-technology regulation, and it coincides with ongoing discussions about telehealth’s role in prescribing medications.