FDA Directs Drugmakers To Make Drugs Less Confusing

Law360, New York (December 13, 2012, 4:38 PM EST) -- The U.S. Food and Drug Administration on Thursday released new draft guidelines on how drugmakers should design and test their products to minimize confusion, medication error and overdose deaths.

The draft guidance document was required under the last round of user fee authorizations, in 2007, after the Institute of Medicine reported that 7,000 people in the U.S. died each year from medication errors.

The new guidelines direct drugmakers to consider how their medications will be used in the real world from the very earliest stages of...
To view the full article, register now.