Compounding Warning Letter Format Unchanged Since Legislation
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA’s first two warning letters since draft compounding guidances may be another way to encourage outsourcer registration.
You may also be interested in...
FDA Compounder Inspections May Help Set New Enforcement Standard
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.
FDA Compounding Definition Brings States Into Oversight Fold
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.
US FDA's FY 2023 User Fees Finally Revealed
Several fees for prescription drug, generic drug, and biosimilar applications are set to increase, although some also will drop.