The State of Pharmaceutical Quality FY21
Introduction On August 25th, the Office of Pharmaceutical Quality (OPQ), part of the FDA’s Center for Drug Evaluation and Research (CDER) released its fourth annual Report on the State of Pharmaceutical Quality, covering fiscal year 2021. Generally speaking, the OPQ is tasked with ensuring that legally marketed drugs in the US are safe, effective, and […]
FDA Virtual Inspections Are Here to Stay – And That’s a Good Thing
The FDA may be easing from its pandemic response mode, but, like any industry and nearly every organization, two years of pandemic have normalized remote work for the agency and forced improvement in remote inspections. The FDA announced during the annual Drug Information Association (DIA) meeting on June 22nd that they do not plan to […]