Shortage Reporting Should Be Over-Inclusive, FDA Tells Drugmakers

19 Mar 2012

• By Martin Berman-Gorvine

Draft guidance urges manufacturers to err on the side of over-reporting when it comes to vital drugs that may be going into shortage.

As FDA seeks to show Congress and the public that it is working hard to alleviate shortages of lifesaving and other important drugs, it is urging manufacturers in a draft guidance to report any possible future shortage or interruption in supply in any drug that might fall into these categories.

The advice to be “over-inclusive” is the major difference in emphasis between the guidance and the interim final...