How FDA’s KASA initiative and structured content streamline regulatory submissions

Moving beyond unstructured text. As early as the 2000s, it was clear that the FDA needed better tools to promote a more agile and flexible pharmaceutical manufacturing sector that could produce high quality drugs reliably with lessened regulatory oversight. For this purpose, they launched several programs and initiatives such as Process Analytical Technology (PAT), Current Good Manufacturing Practices (CGMPs), or Quality by Design (QbD), among many others. But something was still missing, as some issues continued to flow through the system: the lack of an efficient, consistent and objective process for pharmaceutical quality..