CDER World
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:
World of Compliance 
(October 20, 2011)
Course Outline:
- 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
World of Generic Drugs (October 20, 2011)
Course Outline:
- Lesson 1: Generic Drugs Overview
- Lesson 2: Abbreviated New Drug Review Process
World of New Drugs (November 14, 2011)
Course Outline:
- Lesson 1: Role of Office of New Drugs
- Lesson 2: The Drug Review Process
- Lesson 3: Biologics Review
- Lesson 4: Pediatric Regulations
Each module contains a section of Frequently Asked Questions from International Forums. From time to time, as CDER receives questions based on these modules, we will post new questions in the appropriate sections.
As the world of CDER changes or expands, we will modify these modules or develop new modules to bring important information to those interested in the FDA and CDER mission.
Please check back periodically to see when new courses are added to CDER World.
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