title: Does the FDA Owe Us an Explanation?
abstract: The approval process for new medications sometimes appears to require pharmacokinetic data in some circumstances and clinical trial data in others. This editorial calls for more clarity and transparency in the process and uses three examples to raise the issue.
authors.affiliation: Columbia University, New York, NY 10032.
authors.forename: James A
authors.initials: JA
authors.lastname: Reiffel