Compounding: FDA Refining Post-Inspection Hand-off To States
Executive Summary
When the agency finds a traditional compounder during an inspection, it asks state boards of pharmacy to ensure corrections are made.
You may also be interested in...
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.
Compounding The Problem: Congress, FDA Argue Over Regulatory Responsibility
After the House and Senate question whether FDA needs more authority to regulate compounders like the New England Compounding Center, Sen. Lamar Alexander suggests clearly designating who has jurisdiction may be the answer.
Gene Therapy: Pediatric Development Could Start Sooner Than Sponsors Think – FDA OTP Director
Nicole Verdun said children could participate in gene therapy clinical trials earlier if the necessary controls are in place.