The US Food and Drug Administration (FDA) has finalized a guidance to assist sponsors in reporting common changes made to glass vials and stoppers, called container closure systems (CCS), used to hold sterile drug or biological products administered parenterally. The guidance applies to holders of approved new drug applications (NDAs), biologics license applications (BLAs), and abbreviated new drug applications (ANDAs).
The guidance was developed by the Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER) in cooperation with the Center for Biologics Evaluation and Research (CBER)…
