FDA

3D printing of drugs: “the possibilities seem endless”

The possibilities do seem endless, but the Guardian asks whether the 3D printing of medications is safe. They speculate how the pharmacies might change if drugs were printed in local pharmacies, to exact and personalized formulations. The FDA has already given the go-ahead for Spritam levetiracetam (a drug used to control epilepsy) and the hope is to follow with […]

FDA in the Twenty-First Century [Book]

FDA in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies
Edited by Holly Fernandez Lynch and I. Glenn Cohen
A new book, published by Columbia University Press.
 

Especially of interest chapter 26:

A New Regulatory Function for E-Prescriptions: Linking FDA to Physicians and Patient Records, by Andrew English, David Rosenberg, and Huaou Yan

 

And a book review on Health Affairs.

 

January 14th, 2016|Regulation|0 Comments|

Printing Digital Drugs

The Guardian reports on 3D printing drugs. The FDA (US Food & Drug Administration) has approved the printing of a pill containing a new drug, Spritam levetiracetam, (to control epileptic seizures). There are a number of universities across the world working on applying this technology to drugs, hoping to make it safer and more tailored to individual patients.

Full article […]

On the rise of the “translational state” – The State commitment to accelerating the commercial translation of biomedical research

Hogarth, S. “Neoliberal technocracy: Explaining how and why the US Food and Drug Administration has championed pharmacogenomics.” Social Science & Medicine. Available online 15 January 2015 – In Press, Accepted Manuscript
http://www.sciencedirect.com/science/article/pii/S0277953615000313

Abstract:
“By 2004 the FDA had emerged as a champion of pharmacogenomics as an exemplar for novel approaches to drug development. This was made clear in 2004 when […]

On value(s) – epistemic, social, and institutional values

A paper about value base pricing but also about how a classification embodies value :

“What Is the FDA Going to Think?”: Negotiating Values through Reflective and Strategic Category Work in Microbiome Science
Katherine W. Darling, Angie M. Boyce, Mildred K. Cho, and Pamela L. Sankar
in:
Science, Technology & Human Values, January 2015 40: 71-95,
first published on August 4, 2014 […]

August 5th, 2014|Regulation, Value|0 Comments|