Pharmaceutical quality ensures that a patient's medication is safe, effective, and available when needed. The Center for Drug Evaluation and Research (CDER) is responsible for evaluating prescription drug applications to confirm that they meet stringent quality standards. This responsibility encompasses the drug's quality, manufacturing facilities, and the processes involved in production. CDER’s functions extend beyond drug approval, as they continuously monitor drugs on the market and the facilities that produce them to maintain quality.

Pre-Approval Quality Assurance

Before the FDA approves a prescription drug, manufacturers must demonstrate that their products are safe, effective, and meet established quality standards. These standards are uniform across all manufacturers, regardless of location or whether they produce generic or brand-name drugs. CDER's efforts include developing national and international policies to establish these quality benchmarks. They publish guidance documents to help manufacturers understand regulatory requirements and best practices, working with industry organizations and international regulators to advance pharmaceutical quality policies. CDER’s research supports policy development by providing up-to-date scientific information.

Review Process and Inspections

During the drug application review, CDER examines how manufacturers ensure the drug's identity, strength, consistency, and purity. This involves evaluating the manufacturing facility and processes to verify compliance with U.S. laws and regulations. The FDA conducts risk-based assessments of facilities listed in drug applications, including manufacturing, laboratories, and packaging sites. Inspections are a critical tool in this process, especially for new facilities or if significant quality issues are identified. Drugs will not be approved if substantial quality concerns arise during inspections.

CDER maintains an inventory of all facilities involved in the commercial manufacture of U.S. marketed drugs, known as the Site Catalog. Surveillance inspections assess whether these facilities comply with statutory and regulatory requirements, using a risk-based model to prioritize inspections based on factors like compliance history and types of drugs produced.

Monitoring Marketed Drugs

The FDA also inspects manufacturers of non-application drugs, such as many over-the-counter medications, to ensure their quality and safety. CDER may request documents or remote interactions to evaluate compliance with manufacturing practices, using information from international regulatory partners as well.

When safety or quality issues are detected, CDER can recommend actions such as recalls or adding companies to an "import alert" to prevent unsafe products from entering the U.S. Warning letters may also be issued to companies violating manufacturing regulations.

CDER keeps an inventory of all drugs marketed in the U.S., called the Product Catalog, and samples and tests drugs based on risk to monitor for quality issues. With approximately 150,000 drugs in the catalog, selections for testing are based on data from various sources, including FDA investigators and consumers. Decades of sampling have shown that the vast majority of legally marketed drugs meet quality standards.

Concerns about drug quality can be reported to the FDA’s MedWatch program.

Highlights

• CDER ensures pharmaceutical quality by evaluating drug applications, monitoring manufacturing facilities, and conducting inspections.
• Pre-approval processes include proving safety, effectiveness, and compliance with quality standards.
• CDER develops and enforces national and international quality policies, supported by scientific research.
• Risk-based inspections of manufacturing facilities are essential for drug approval and ongoing quality assurance.
• CDER maintains detailed inventories of manufacturing sites and marketed drugs, sampling and testing products to ensure compliance.
• Safety or quality concerns can result in recalls, import alerts, or warning letters.
• The MedWatch program is available for reporting drug quality issues.