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FDA Developing Framework that Could Allow Prescription Drug Software Developers to Sidestep Review


The FDA hopes the framework will help patients improve their health.

New FDA framework could allow prescription drug software developers to skip formal review.

The U.S. Food and Drug Administration (FDA) is creating a framework that could enable most prescription drug software developers to avoid formal review.The FDA said the rules will help guide the safe and effective use of medicines and help patients improve their health. Officials are looking for stakeholders and the public’s opinion to learn more ways to develop guidelines for prescription drug-related software.

With the advancement of digital health technologies and their increased used in everyday health decisions, most advances have been on the delivery side of healthcare, where digital tools are helping inform medical decisions by patients and providers, according to the regulator.

“…The FDA wants to promote the development of digital technologies that can also help guide the safe and effective use of medicines, to help patients improve their health,” FDA Commissioner Scott Gottlieb, M.D., said in a briefing.

>> READ: After FDA Approval, Pear Therapeutics Releases Drug Treatment mHealth App reSET

The agency is seeking input on new steps to modernize the approach to overseeing software products that complement prescription drugs.

For example, a sensor that collects data to track a drug as it’s moving through the body after ingestion can give insights into the real-world performance of a medication. Software might also allow patients to track symptoms to inform their discussions with provider. What’s more, an app could help patients be more aware of a drug’s treatment effects.

“The proposed framework is designed to take a risk-based approach to prescription drug-use-related software,” the FDA said in a notice. “Under this approach, it is anticipated that in most cases, the output of such software will not require review by the FDA prior to dissemination.”

The approach also fosters innovation and use of digital technologies with prescription drugs, leveraging FDA’s existing mechanisms.

Prescription drug-use-related software refers to software disseminated by or on behalf of a drug sponsor that accompanies one or more of the sponsor’s prescription drugs.

The public docket, which is open until Jan. 22, 2019, allows the public to comment electronically or via paper submissions. The docket was established to solicit public comment on a proposed framework for regulating software application disseminated by or on behalf of drug sponsors for use with one or more of their prescription drug products, according to the notice.

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