On the 14th of November the FDA released a proposed framework which means that software released by pharma could be given a “promotional label”, in order to avoid the lengthy premarket review process.

The proposal means most drug companion apps and software released by pharma would only require submission to the FDA’s Office of Prescription Drug Promotion (OPDP) or Advertising and Promotional Labeling Branch (ABLB).

Last weeks’ article by Dave Muoio at MobiHealth News discusses the impact this will have on the industry, plus outlines how some leaders in this space have responded to this announcement.

  • Access the full article here

  • Read the FDA’s proposed framework here (open to public comment for 60 days):

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