U.S. FDA Drug Development and Approval Process Overview

1. CDER Mission and Role

The mission of FDA's Center for Drug Evaluation and Research (CDER) is to ensure that drugs marketed in this country are safe and effective. CDER does not test drugs, although the Center's Office of Testing and Research does conduct limited research in the areas of drug quality, safety, and effectiveness. Source: https://www.fda.gov/drugs/development-approval-process-drugs/how-drugs-are-developed-and-approved

2. Sponsor Responsibility

It is the responsibility of the company seeking to market a drug to test it and submit evidence that it is safe and effective. A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the sponsor's NDA containing the data and proposed labeling. Source: https://www.fda.gov/drugs/development-approval-process-drugs/how-drugs-are-developed-and-approved

3. Application Types

• Investigational New Drug (IND) Application
• New Drug Application (NDA)
• Abbreviated New Drug Application (ANDA)
• Therapeutic Biologics Applications (BLA)
• Drug Applications for Over-the-Counter (OTC) Drugs

Bringing Nonprescription Drug Products to the Market Under an OTC Monograph: OTC drugs can be brought to the market following the NDA process or under an OTC monograph. Each OTC drug monograph is a kind of “recipe book” covering acceptable ingredients, doses, formulations, labeling, and, in some cases, testing parameters. Products conforming to a monograph may be marketed without FDA pre-approval. Source: https://www.fda.gov/drugs/development-approval-process-drugs/how-drugs-are-developed-and-approved

4. Additional Resources

For more information on the drug development and approval process, see:

• Guidance for Industry
• CDER Small Business and Industry Assistance
• Clinical Trials and Human Subject Protection
• Surveillance
• Training and Continuing Education (CDERLearn) Source: https://www.fda.gov/drugs/development-approval-process-drugs/how-drugs-are-developed-and-approved