The FDA’s Final Guidance on Mobile Medical Apps as a Medical Device—and What It Means for Pharma and Its Agency Partners

By | 2016-11-04T16:58:00+00:00 September 27, 2013|Viewpoints|
Bob Palmer, EVP, Digital Practice

Bob Palmer, EVP, Digital Practice

This post is an excerpt from Bob Palmer’s section of a multi-perspective post on the Digital Health Coalition’s website.

The FDA’s final guidance on mobile medical applications has elicited a collective sigh of relief throughout the pharmaceutical industry and its agencies. The FDA has not handcuffed pharma with unreasonable or burdensome regulation; to the contrary, it has taken a relatively enlightened approach.

But for pharmaceutical marketers and regulators there are potential unintended consequences that could inhibit innovation or add to the time and expense of bringing new apps to market. As is the case with the digital revolution in general, cultural shifts need to happen for those who want to capitalize on technological advances.

Read the full report on the DHC website and let us know your thoughts in the comments below.

 

About the Author:

Robert Palmer
EVP, Digital Innovation Officer

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