CDER’s Regulatory Science Program Areas
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CDER’s diverse research programs address a wide variety of critical areas that affect drug safety and manufacturing quality. CDER’s regulatory science programs areas include:
- Applied regulatory science
- Clinical pharmacology
- Clinical trial methodology
- Drug safety monitoring
- Generic drugs and bioequivalence
- Manufacturing innovation
- Prescription drug advertising and risk communication
- Product quality assessment
- Radioactive Drug Research Committee (RDRC) Program
Applied regulatory science. Applied regulatory science moves new science into CDER's review process. CDER scientists seek to develop laboratory data, data-based tools, best practices, and approaches that can address immediate and emerging regulatory science issues that CDER reviewers encounter during the drug development and approval process.
Biomarkers. CDER scientists help identify, develop, measure, and evaluate new biomarkers, which can help predict toxicities and long-term clinical outcomes and help providers tailor treatments to individual patients. Biomarkers help ensure safety and efficacy in drug development and streamline the development process. Learn more about CDER's Biomarker Qualification Program.
Clinical pharmacology. CDER scientists study drugs in humans by looking at both what the body does to the drug and what the drug does to the body. This work is critical to determining safe and effective doses for patients. It also helps identify individual differences in responses to drugs. Research in pharmacogenomics, for example, is helping CDER scientists identify the best possible treatment options for individual patients.
Clinical trial methodology. CDER scientists are helping accelerate drug development by making clinical trials more informative and efficient. For example, CDER is working on improving the testing for cardiotoxicity in clinical trials.
Drug safety monitoring. CDER scientists evaluate new drugs before they can go on the market and monitor approved drugs for unexpected health risks. For example, CDER tracks and monitors drug-induced liver toxicity, which is a growing concern as the population ages and more people use multiple drugs. Learn more about CDER's various postmarketing drug safety efforts, including FDA's Sentinel Initiative.
Generic drugs and bioequivalence. CDER's generic drug regulatory science program helps ensure that generic versions of drugs are available to the public, by developing new ways to evaluate the generic drugs' physical and pharmacologic properties. Learn more about recent progress in the Office of Generic Drugs FY 2015 Regulatory Science Research Report.
Manufacturing innovation. CDER supports research to modernize drug manufacturing so that safe, high-quality drugs can be produced efficiently. Areas of investigation include continuous processing, analytical technology to monitor and control manufacturing, and new statistical approaches to quickly detect changes in process or product quality. Learn more about the impact of CDER's research in continuous manufacturing and about CDER's Office of Pharmaceutical Quality.
Prescription drug advertising and risk communication. CDER's Office of Prescription Drug Promotion investigates how materials promoting prescription drugs communicate risk and benefit information to consumers and professionals.
Product quality assessment. CDER sets drug quality standards in a variety of ways, including encouraging innovation in manufacturing and finding new ways to ensure drugs' quality. Learn more about FDA's drug quality sampling and testing programs.
Radioactive Drug Research Committee (RDRC) Program. CDER's RDRC program permits basic research using radioactive drugs in humans without an Investigational New Drug Application when the drugs are administered under certain conditions.