Generic Drug Industry Warned Of Impending Deficiency Letters For Pre-Filled Syringes
This article was originally published in The Gold Sheet
Executive Summary
An official with the generic drug industry warned of a potential onslaught of ANDA deficiency letters going to manufacturers of generic drugs combined with needleless pre-filled glass syringes and connecting devices for not adhering to FDA guidance. FDA is now requiring more data to ensure the safety of these products, including human factors testing and performance testing.