The US Food and Drug Administration (FDA) has issued draft guidance aimed at improving the consistency of information in the dosage and administration section of prescription drug labeling. Such consistency will ensure that labeling is “pertinent and understandable” to health care practitioners, said the agency.
The draft is a wholesale rewrite of an earlier guidance issued in March 2010, which has now been withdrawn. The new guidance, which is roughly triple the length of the previous one, goes into greater detail on dosage and administration information for specific drug types and addressing special populations…
