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Why it matters that the FDA just approved the first 3D-printed drug

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In a 2012 TED Talk, Lee Cronin of the University of Glasgow describes a new approach to 3D printing that could potentially enable patients to print their own medicines at home.

While the home 3D printing of drugs may not be possible any time soon, it might be possible to 3D print sample tissues and organs for drug testing purposes. Add in the “Gee whiz” aspect of 3D printing, and it’s easy to see potential regulatory nightmares facing other FDA approvals. The FDA seems remarkably open to the idea of 3D printing, even while it acknowledges that the regulatory hurdles could be considerable. Even before it approved the 3D printed pill, the agency had already approved the first 3D printed prosthetic. Last year, the FDA held a workshop on 3D printing for medical device makers, which can be viewed as an encouraging signal to continue on the same 3D printing path.

Aprecia Pharmaceuticals, the company that pioneered the concept of the 3D-printed pill, has already received more than 50 patents related to pharmaceutical applications for 3D printing, and has promised to bring new neurological drugs to market that are made via 3D printing.


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Post Author: Carla Parsons

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