Compounding Warning Letter Format Unchanged Since Legislation
This article was originally published in The Pink Sheet Daily
FDA’s first two warning letters since draft compounding guidances may be another way to encourage outsourcer registration.
You may also be interested in...
Agency releases 483 forms from a post-crises inspection push; the effort may help FDA illustrate its inspection capabilities to Congress and states and indicate the agency’s oversight plans under the new authority it has proposed.
State regulators seem to agree with FDA about confusion over regulatory responsibility, saying writing consistent definitions for compounding and manufacturing will help determine future FDA involvement.
Several fees for prescription drug, generic drug, and biosimilar applications are set to increase, although some also will drop.