Prescription Drug Use-Related Software
The FDA’s draft guidance, Regulatory Considerations for Prescription Drug Use-Related Software (PDURS), establishes a framework for regulating how software can enhance prescription drug use. This framework impacts labeling and software requirements, and DTA has formed a dedicated PDURS Task Group to navigate these changes.
DTA’s PDURS Task Group —comprised of digital health manufacturers, pharma companies, law firms, and subject matter experts—is already identifying potential hurdles and crafting strategies to navigate them. We’re actively collaborating with the FDA, OIG, and CMS to address regulatory, compliance, and reimbursement challenges.
Read DTA’s PDURS Comment Letter
Read Andy Molnar’s PDURS Thought Piece
