FDA’s OPQ reports on drug quality efforts in 2020

The Office of Pharmaceutical Quality (OPQ) within FDA’s Center for Drug Evaluation and Research (CDER) has released its annual report for 2020. OPQ said it was able to use alternative tools instead of conducting 153 on-site facility inspections during the pandemic. OPQ revealed that more than 95% of applications subject to user fee goals were acted on by their goal date. In 2020, OPQ said it enabled the approval of 942 generic drugs, of which 72 were first generics, two were complex generics, and three were biosimilars. The office also said it approved more than 10,000 quality-related changes for previously approved products during the year. Furthermore, OPQ highlighted its role in CDER’s emerging technology program, which enables early engagement with companies to promote the use of advanced manufacturing technologies. OPQ said the program in 2020 received nine regulatory submissions, accepted 16 proposals, and conducted 40 industry meetings. Regarding its Knowledge-aided Assessment & Structured Application tool, the office said: “In early 2021, OPQ will begin using knowledge-aided assessment interfaces for solid oral dosage forms, manufacturing, and biopharmaceuticals.” OPQ is responsible for performing quality assessments for human drug applications, including investigational new drug applications, new drug applications, abbreviated new drug applications, and biologics license applications. The office is also tasked with overseeing the quality of OTC drugs and compounded drugs.