Generic Industry Has Made Progress Implementing QbD
This article was originally published in The Gold Sheet
Executive Summary
The generic drug industry has progressed swiftly with QbD, reports an FDA OGD official. The share of ANDAs containing QbD elements has tripled from 25% in June 2012 to 83% in January 2013 – while brands struggled to reach 14% QbD last year with their NDA filings.