Making the Work of CDER Transparent on the Web
For many years, the U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER) has reached out to its international regulatory colleagues. Since 2005, CDER has held the CDER Forum for International Drug Regulatory Authorities every spring and fall so international regulators can learn first-hand how CDER organizes the drug review process and carries out its mission of ensuring the safety and efficacy of human drug products in the United States.
The interest in these "live" meetings has grown exponentially with FDA working in harmonization with countries around the world. Many more people than can be accommodated at these small meetings want to learn about the science, technology, regulations and processes CDER uses to accomplish its complex and challenging work. To respond to this great interest, the Center has developed "CDER World."
"CDER World," is an ever-growing compendium of information about how CDER carries out its mission, adapts to new legislative initiatives, and initiates directions in regulatory science to improve the public health.
CDER will populate these Web pages with information based on the CDER International Forum series. CDER World will expand as modules are developed, designed and posted on the Web.
E-learning courses currently available in CDER World:
- Lesson 1: Introduction to FDA Human Drug Review and Approval Basics
- Lesson 1: World of CDER Advisory Committee Process
- Lesson 1: Office of Compliance Overview
- Lesson 2: Manufacturing and Product Quality
- Lesson 3: Scientific Investigations
- Lesson 4: Bioequivalence and Good Laboratory Practice Inspection Programs
- Lesson 5: Enforcement Responsibilities
- Lesson 6: Risk Management and Drug Surveillance
- Lesson 1: Generic Drugs Overview
- Lesson 2: Abbreviated New Drug Review Process
- Lesson 1: Role of Office of New Drugs
- Lesson 2: The Drug Review Process
- Lesson 3: Biologics Review
- Lesson 4: Pediatric Regulations
Activities and responsibilities of CDER's Office of Surveillance and Epidemiology (OSE)