Proposed FDA Drug Software Rules Strict On Pharma Cos.

By Albert Cacozza, Kellie Combs, Joshua Oyster and Rebecca Williams (December 10, 2018, 2:55 PM EST) -- On Nov. 20, 2018, the U.S. Food and Drug Administration issued a Federal Register notice seeking public comment on the FDA's proposed framework for regulating prescription drug-use-related software, or PDURS, the agency's latest move in modernizing the regulatory requirements for digital health technologies. Under the proposed framework, which the FDA intends to develop into a draft and, ultimately, a final guidance document, the FDA would regulate the output of PDURS — software "disseminated by or on behalf of a drug sponsor that accompanies one or more of the sponsor's prescription drugs (including biological drug products)" — as drug labeling. As such, the software output would be subject to the FDA's regulations for FDA-required labeling or promotional labeling, as applicable....

Law360 is on it, so you are, too.

A Law360 subscription puts you at the center of fast-moving legal issues, trends and developments so you can act with speed and confidence. Over 200 articles are published daily across more than 60 topics, industries, practice areas and jurisdictions.

A Law360 subscription includes features such as

  • Daily newsletters
  • Expert analysis
  • Mobile app
  • Advanced search
  • Judge information
  • Real-time alerts
  • 450K+ searchable archived articles

And more!

Experience Law360 today with a free 7-day trial.

Start Free Trial

Already a subscriber? Click here to login

Hello! I'm Law360's automated support bot.

How can I help you today?

For example, you can type:
  • I forgot my password
  • I took a free trial but didn't get a verification email
  • How do I sign up for a newsletter?
Ask a question!