FDA Quietly Announces Office Of Pharmaceutical Quality Restructure

FDA’s Center for Drug Evaluation and Research (CDER) is reorganizing its Office of Pharmaceutical Quality (OPQ) as it works on a broader effort to stem drug shortages by encouraging manufacturers to go beyond regulatory requirements in addressing quality issues. The changes will consolidate research functions and quality assessments, among other alterations. The changes were announced in an email from center director Patrizia Cavazzoni to OPQ staff and are scheduled to take effect Jan. 14, 2024. While the announcement was shared...