Center for Drug Evaluation and Research

FDA Bldg 51 - Main Entrance (5161374834)

Center for Drug Evaluation and Research

The Center for Drug Evaluation and Research (CDER) is a division of the United States Food and Drug Administration (FDA), which is responsible for ensuring that drugs marketed in the United States are safe and effective. CDER oversees the regulation of both prescription and over-the-counter (OTC) drugs, including biological therapeutics and generic drugs.

History

CDER was established to consolidate the drug regulatory functions of the FDA. Over the years, it has evolved to address the growing complexity of drug development and the increasing number of new drug applications.

Functions

CDER's primary functions include:

• Reviewing new drug applications (NDAs) and biologics license applications (BLAs) to ensure that drugs are safe and effective for their intended use.
• Monitoring the safety of drugs post-approval through the FDA Adverse Event Reporting System (FAERS).
• Regulating the advertising and promotion of prescription drugs to ensure that information is truthful and not misleading.
• Conducting research to support drug evaluation and regulatory decision-making.
• Providing guidance to the pharmaceutical industry on drug development and regulatory requirements.

Organizational Structure

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

• Office of New Drugs (OND)
• Office of Generic Drugs (OGD)
• Office of Compliance (OC)
• Office of Surveillance and Epidemiology (OSE)
• Office of Pharmaceutical Quality (OPQ)

Drug Approval Process

The drug approval process at CDER involves several stages: 1. Preclinical Testing: Before testing in humans, drugs undergo laboratory and animal testing to assess safety and biological activity. 2. Investigational New Drug (IND) Application: Sponsors must submit an IND application to the FDA before beginning clinical trials in humans. 3. Clinical Trials: Clinical trials are conducted in three phases to evaluate the drug's safety, efficacy, and optimal dosing. 4. New Drug Application (NDA): After successful clinical trials, sponsors submit an NDA, which includes all data from preclinical and clinical studies. 5. FDA Review: CDER reviews the NDA to determine whether the drug is safe and effective for its intended use. 6. Post-Market Surveillance: After approval, CDER continues to monitor the drug's safety through adverse event reporting and other surveillance activities.

Significance

CDER plays a crucial role in public health by ensuring that drugs available to consumers are safe and effective. Its work helps to prevent harmful drugs from reaching the market and provides valuable information to healthcare providers and patients.

See Also

• United States Food and Drug Administration
• Drug development
• Clinical trial
• Pharmacovigilance
• Biologics License Application
• Generic drug