FDA is taking the next step towards gathering and reporting manufacturing quality metrics data by releasing a draft guidance outlining an initial list of proposed metrics. However, FDA made clear during an August feedback meeting that it isn’t going to rush the changes through.

FDA completed a major reorganization of the way it regulates manufacturing quality of drugs and biologics with the launch of the Office of Pharmaceutical Quality within the Center for Drugs. OPQ is part of Janet Woodcock’s decade-long effort to ensure a consistent, safe drug supply. The immediate impact on industry will be minimal, but manufacturers that haven’t invested in facility upgrades will face a steep learning curve.

FDA’s second wave of Breakthrough Therapies will look markedly different from the initial flurry of approvals. After an early focus on oncology, FDA is reviewing a more diverse set of applications in the antiviral, vaccines and cardiovascular arenas. And there will be more “breaks” during development as sponsors start to request designations based on earlier data. What will Breakthrough look like in the third year of the program?