Back to Regulatory Science at CDER
One of FDA’s major goals is to modernize the regulation of pharmaceutical manufacturing and enhance product quality. As part of its comprehensive approach to quality oversight across the drug product lifecycle, CDER conducts research to support the development of scientific standards and policies related to quality, safety, and effectiveness of human drug products.
Product quality research studies help to address unresolved regulatory science questions and prepare the organization for emerging science issues and technologies. Results from this research have directly informed review decisions, impacted or revised agency guidance and policies, and protected the public health by ensuring that high-quality products reach the American people.
One of the many areas of product quality research supported by CDER is manufacturing science and innovation. Learn about the impact of CDER's research on continuous manufacturing, a quicker and more reliable way to make drugs and drug components than the common practice of manufacturing drugs step-wise in batches.