Back to Regulatory Science at CDER
Scientific knowledge steers the drug approval decision-making process of the Center for Drug Evaluation and Research (CDER).
FDA scientists conduct laboratory, clinical and statistical research to proactively address knowledge gaps created by advances in drug development and healthcare technologies, or to address safety questions that arise during post-market drug monitoring. Learn more about some of their research goals:
- Streamline and improve the process for predicting drug's toxicity
- Reduce the time needed to identify the benefits of a new drug over an existing treatment
- Identify more precisely who will benefit from a drug
- Improve product quality and reduce the threat of drug shortages
- Develop new tools and capabilities to respond quickly to threats to public health
- Advance scientific knowledge and reduce duplication of effort by making electronic data more useable and accessible to researchers and developers
- Improve surveillance of marketed drugs to protect the public health
- Develop new methods to support generic drug approval decisions and ensure safety and effectiveness after those drugs are marketed
In Action: CDER has a variety of programs aimed at predicting drug toxicity more quickly and reliably. For example, quantitative structure-activity and relationship (QSAR) models have been developed by CDER scientists and statisticians to help developers predict the properties of new molecules before investing in costly animal studies. Similarly, CDER has also made significant progress in predicting the cardiotoxicity of drugs during clinical trials.
In Action: The gold standard of clinical endpoints for many drugs is the overall survival of patients, but completing studies that use this endpoint can take years. CDER scientists are evaluating surrogate endpoints that are correlated with patient survival but emerge much more quickly. For example, there have been major studies of two possible surrogate endpoints—pathologic complete response (in breast cancer) and objective response rate (in a form of lung cancer)—to determine how well they correlate with survival endpoints.
In Action: CDER scientists are conducting research to help identify which patients with viral hepatitis and certain types of cystic fibrosis would benefit from new medicines. CDER scientists also help get those medicines approved.
In Action: Interruptions in manufacturing due to human error are a major cause of drug shortages. CDER-funded research has helped to make drug manufacturing faster and safer, with a process called continuous manufacturing.
In Action: Antibiotic resistance, which renders many common antibiotics ineffective, is an emerging threat to public health. To help address this problem, CDER statisticians helped develop a novel clinical trial design, the Desirability of Outcome Ranking with Response Adjusted for Duration of Antibiotic Risk (DOOR/RADAR), to analyze antibiotic treatment regimens.
In Action: CDER scientists are developing easily searchable databases to make existing data available to scientists working on new projects. For example, new databases are making it easier to find toxicity data in FDA archives by linking the data to chemical structures, allowing a more efficient and precise search. Learn more about CDER's databases.
In Action: CDER is creating a system called Sentinel for active surveillance of large health care databases. Sentinel will greatly extend FDA's ability to identify and develop strategies to mitigate harms associated with certain drug products.
In Action: To speed decision making about whether to approve generics, CDER is developing new tools and methods, such as open-flow microperfusion for assay of drugs like acyclovir that are applied to the skin.