FDA changes begin to appear

WASHINGTON - The FDA last week published documentation promised as part of its planned administrative reforms of agency procedures. The first document is intended to fulfill a commitment of the Clinton administration to reduce through guidance the number of manufacturing changes that require preapproval by FDA.

The guidance provides recommendations to sponsors of NDAs, AADAs, and ANDAs "who intend, during the postapproval period, to change the components or composition of the drug, site of manufacture, scale-up/scale-down of manufacture, and/or manufacturing process or equipment."...