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  1. Science and Research | Drugs

CDER’s Regulatory Science Program Areas

Addressing a wide variety of critical areas that affect drug safety and manufacturing quality

Our diverse research programs address a wide variety of critical areas that affect drug safety and manufacturing quality. Our regulatory science programs areas include:

Applied regulatory science

The Division of Applied Regulatory Science moves new science into CDER's review process. Our scientists seek to develop laboratory data, data-based tools, best practices, and approaches that can address immediate and emerging regulatory science issues that our reviewers encounter during the drug development and approval process.

Biomarkers

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 the Biomarker Qualification Program.

Clinical pharmacology

Scientists in the Office of Clinical Pharmacology 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 scientists identify the best possible treatment options for individual patients.

Clinical trial methodology

Through efforts like the Complex Innovative Designs (CID) Pilot Program, CDER scientists in the Office of Biostatistics are helping to accelerate drug development by making clinical trials more informative and efficient.

Drug Development Tool (DDT) Qualification Programs

DDTs are methods, materials, or measures that have the potential to facilitate drug development. They allow us to work with submitters to guide them as they develop DDTs for specific contexts of use.

Drug safety monitoring

Scientists evaluate new drugs before they can go on the market and monitor approved drugs for unexpected health risks. Learn more about various postmarketing drug safety efforts, including FDA's Sentinel Initiative.

Generic drugs and bioequivalence

The 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 the Office of Generic Drugs.

Manufacturing innovation

We support 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.

Modernizing drug review

The Office of New Drugs conducts research to reduce uncertainty around regulatory decision making and streamline regulatory review.

Prescription drug advertising and risk communication

The Office of Prescription Drug Promotion investigates how materials promoting prescription drugs communicate risk and benefit information to consumers and professionals.

Product quality assessment

Our research ensures drug quality in a variety of ways, including encouraging innovation in manufacturing and finding new ways to ensure drugs' quality. Learn more about our drug quality sampling and testing programs and research to ensure the safety and effectiveness of medical products in the Office of Pharmaceutical Quality.

Radioactive Drug Research Committee (RDRC) Program

The RDRC program permits basic research using radioactive drugs in humans without an Investigational New Drug Application when the drugs are administered under certain conditions.

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