Despite the pandemic, FDA has worked to maintain appropriate oversight of biopharmaceutical production activities, while also advancing strategies to encourage industry adoption of advanced manufacturing systems. The larger goals of enhanced quality production are to prevent drug shortages and ensure adequate supplies of needed medical products, as outlined in a number of studies and initiatives. Several policies and programs encourage purchasers of drug ingredients and of finished products to consider a firm’s ability to consistently produce high-quality products, an approach that fits broader federal “buy American” programs seeking to avoid supply chain problems that arise from import delays and difficulties.
