How long before the FDA won’t approve a novel therapeutic unless it has an App?

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“Question  Are characteristics of novel therapeutics known at the time of US Food and Drug Administration (FDA) approval associated with postmarket safety events, including withdrawal, boxed warnings, and safety communications?

Findings  Among 222 novel therapeutics approved by the FDA from 2001 through 2010, 71 (32.0%) were affected by a postmarket safety event. Postmarket safety events were more frequent among biologics, therapeutics indicated for the treatment of psychiatric disease, those receiving accelerated approval, and those with near–regulatory deadline approval.

Meaning  Postmarket safety events are common after FDA approval, highlighting the importance of continuous monitoring of the safety of novel therapeutics throughout their life cycle”

mHealth Insight

With 32% of novel approved therapeutics being approved being affected by a postmarked safety event isn’t in incredible that the FDA isn’t already requiring new drugs to be made available with apps that at the very least provide the Patient Information (that is normally printed in tiny text on fiddly pieces of paper that can be found in the box) together with a dose calculator, medication reminder and the ability to share feedback and report concerns.

Related Posts:

Successful mHealth applications are already here (August 2009)

FDA interest in iPhone validates the power of mHealth (May 2010)

What hope have the FDA of understanding mHealth? (July 2011)

Why are we talking about how the FDA MIGHT negatively impact the development of mHealth services when it already is? (June 2012)

The first rule of FDA regulation of mHealth: You don’t talk about FDA regulation of mHealth (July, 2012)

Recording of EyeforPharma’s “Beyond the Pill” webinar now live (June 2013)

The International Diabetes Federation calls for mHealth to become an embedded compulsory part of how we provide quality care for diabetics (Feb 2014)

About David Doherty
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