The
process of prescribing, dispensing and using 
medications leaves little room for
medical errors when the health of the consumer is at stake.
The
same holds true in making sure there is no room for error in “dispensing”
prescription drug and medical device information on your web sites. The new FDA
guidelines present the opportunity to ensure your customers can and will find
readily accessible and accurate off-label information across your company and
branded web properties. With the new FDA guidance for responding to unsolicited
requests for off-label information, it may be time for a cross-domain audit of
your web properties – an audit to simply ensure such off-label information is
current and meeting FDA requirements.
Per
the FDA recommendations, a firm’s contact and disclosure information, a
public response should include a mechanism for providing readily accessible
current FDA-required labelling, if any, for the product (e.g., FDA-approved
package insert and, if the response is for a consumer, FDA-approved patient labelling
or, for new animal drugs, FDA-approved client information sheet. Read full post »
