Center for Drug Evaluation and Research

Overview

The Center for Drug Evaluation and Research (CDER) is a division of the U.S. FDA responsible for ensuring that drugs marketed in the United States are safe and effective. CDER's mission encompasses the regulation of both prescription and over-the-counter (OTC) drugs, including biologics and generic drugs. The center plays a critical role in the drug approval process, post-market surveillance, and the development of regulations and guidelines for drug manufacturing and distribution.

History

CDER was established in 1987, evolving from earlier FDA divisions focused on drug regulation. The center's creation was part of a broader effort to streamline and enhance the FDA's ability to oversee the burgeoning pharmaceutical industry. Over the years, CDER has adapted to new scientific advancements and regulatory challenges, including the rise of biotechnology and the globalization of drug manufacturing.

Organizational Structure

CDER is organized into several offices and divisions, each specializing in different aspects of drug evaluation and regulation. Key components include:

Office of New Drugs (OND)

The OND is responsible for reviewing new drug applications (NDAs) and biologics license applications (BLAs). It is divided into various review divisions based on therapeutic areas, such as oncology, cardiology, and neurology.

Office of Generic Drugs (OGD)

The OGD oversees the approval of generic drugs through the abbreviated new drug application (ANDA) process. This office ensures that generic drugs meet the same standards of quality, safety, and efficacy as their brand-name counterparts.

Office of Compliance (OC)

The OC monitors drug manufacturing practices to ensure compliance with GMP regulations. This office conducts inspections, enforces regulatory actions, and works to prevent the distribution of substandard or counterfeit drugs.

Office of Surveillance and Epidemiology (OSE)

The OSE is tasked with post-market surveillance of drugs. It monitors adverse drug reactions, conducts epidemiological studies, and assesses the safety of drugs once they are on the market.

Office of Translational Sciences (OTS)

The OTS provides scientific support for drug evaluation, including pharmacology, toxicology, and clinical pharmacology. This office also develops new methodologies and tools to enhance drug review processes.

Drug Approval Process

The drug approval process at CDER involves several stages, including preclinical testing, clinical trials, and regulatory review.

Preclinical Testing

Before a drug can be tested in humans, it must undergo extensive preclinical testing in laboratories and animal studies. These tests assess the drug's safety, pharmacokinetics, and pharmacodynamics.

Clinical Trials

Clinical trials are conducted in three phases:

**Phase I:** Tests the drug's safety and dosage in a small group of healthy volunteers.
**Phase II:** Evaluates the drug's efficacy and side effects in a larger group of patients with the target condition.
**Phase III:** Confirms the drug's effectiveness and monitors adverse reactions in a large patient population.

Regulatory Review

Once clinical trials are completed, the sponsor submits an NDA or BLA to CDER. The application includes data from preclinical and clinical studies, manufacturing information, and proposed labeling. CDER reviewers assess the application to determine whether the drug is safe and effective for its intended use.

Post-Market Surveillance

After a drug is approved, CDER continues to monitor its safety and efficacy through post-market surveillance. This includes:

**Adverse Event Reporting:** Healthcare professionals and patients can report adverse drug reactions to the FDA's MedWatch program.
**Risk Evaluation and Mitigation Strategies (REMS):** Some drugs require REMS to ensure that their benefits outweigh their risks.
**Periodic Safety Updates:** Drug manufacturers must submit periodic safety reports to CDER, summarizing new safety information and any actions taken to mitigate risks.

Regulatory Science and Innovation

CDER is committed to advancing regulatory science to improve drug evaluation and regulation. This includes:

**Biomarkers and Surrogate Endpoints:** Developing and validating biomarkers to predict drug efficacy and safety.
**Model-Informed Drug Development (MIDD):** Using computational models to inform drug development and regulatory decisions.
**Real-World Evidence (RWE):** Leveraging data from electronic health records, claims databases, and patient registries to assess drug safety and effectiveness.

International Collaboration

CDER collaborates with regulatory agencies worldwide to harmonize drug regulations and facilitate the global availability of safe and effective drugs. Key initiatives include:

**International Council for Harmonisation (ICH):** Developing harmonized guidelines for drug development and regulation.
**Mutual Recognition Agreements (MRAs):** Agreements with other regulatory agencies to recognize each other's inspection reports and regulatory decisions.

Challenges and Future Directions

CDER faces several challenges in its mission to ensure drug safety and efficacy, including:

**Emerging Technologies:** Adapting regulatory frameworks to accommodate new technologies such as gene therapy and personalized medicine.
**Global Supply Chain:** Ensuring the quality and safety of drugs manufactured and distributed globally.
**Opioid Crisis:** Addressing the public health crisis related to opioid misuse and addiction.

Future directions for CDER include enhancing regulatory science, improving patient engagement, and leveraging advanced data analytics to inform regulatory decisions.