[e-drug] Draft FDA guidelines on patient leaflets CMI

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E-DRUG: Draft FDA guidelines on patient leaflets CMI
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Different words often used for the same thing:
CMI - Consumer Medication Information
PIL - Patient Information Leaflet
Package insert
Patient leaflet

The Food and Drug Administration in US has issued a draft Guidance on Useful
Written Consumer Medication Information (CMI).

http://www.fda.gov/cder/guidance/6520dft.htm

The document is already outdated by 20 years. They state that CMIs should be
useful, but provide no criteria for this.

In Australia, David Sless at Communication Research Institute of Australia, CRIA has
developed criteria and methods for making useful CMIs. They have been available
for ten years.

http://www.communication.org.au/

Any ideas how to make FDA realise their anachronism?

Stein Lyftingsmo
Hospital Pharmacy of Elverum, Norway
stein@lyftingsmo.no
www.lyftingsmo.no