Welcome to CDERLearn, the web page for educational tutorials offered by the Center for Drug Evaluation and Research (CDER). CDER's primary mission is to make certain that safe and effective drugs are available to the American people. There is, however, a strategic initiative to inform and educate people about the safe use of medicine, the drug regulatory process, the vital role health care professionals play to assist FDA in fulfilling its duties, and many other important issues. Online training is one way to share FDA expertise with many more people than face-to-face classroom sessions would allow, and we will offer additional CDERLearn courses in the future.
FDA’s Role in Public Health: Drug Efficacy, Safety, Quality, and Beyond
The purpose of this continuing education (CE) course is to educate a national audience of health care providers, industry, and consumers about the basics of the FDA drug regulatory process and the science that supports CDER’s mission. The course will also educate the nation’s health care providers about their role in communicating drug information to their patients. This updated CDERLearn course replaces the former CDERLearn course, "The Past, Present, and Future of Human Drug Regulation."
FDA Overview of Biosimilar Products
This continuing education (CE) course provides an understanding of biological products and biosimilar products and a description of FDA’s general approach to the development and approval of biosimilar products. The target audience for this course is healthcare professionals, including physicians, physician assistants, nurses, nurse practitioners, and pharmacists.
CDER Small Business and Industry Education Series
CDER's Small Business and Industry Assistance Program has developed a series of Web-based courses to educate regulated small pharmaceutical industry. Note that these courses take approximately 1-3 hours to complete.
- Best Practices for Communication Between FDA and IND Sponsors During Drug Development
The course describes best practices and procedures for timely, transparent, and effective communications between investigational new drug application (IND) sponsors and FDA at critical junctures in drug development.
- Overview of the Generic Drug User Fee Amendments of 2012 (GDUFA)
This course informs the user about the GDUFA requirements and process, and can serve as a resource for better understanding of GDUFA. It addresses the rationale and benefits of GDUFA, the review and fee commitments under GDUFA, the metrics and goals associated with GDUFA, the self-identification process, and the drug master file changes required under GDUFA.
- GDUFA Self-Identification (SPL) Submission – Part 1
This course is Part 1 of a two-part web-based training course on GDUFA Self-Identification SPL Submission. The overall goal of this training module is to provide a clearer understanding of mandatory information and its format for self-identification under GDUFA. It offers a comprehensive review of the required data elements and their restrictions for the Self-Identification SPL file.
- GDUFA Self-Identification (SPL) Submission – Part 2
This course is Part 2 of a two-part web-based training course on GDUFA Self-Identification SPL Submission. It focuses on guiding firms through a successful self-identification submission process, including uploading SPL submissions and retrieving acknowledgements.
- Bringing an Over-the-Counter (OTC) Drug to Market
The purpose of this course is to provide information on navigating the rules and regulations on bringing an OTC drug to market and the associated FDA processes.
- Chemistry, Manufacturing, and Controls (CMC) Perspective of the IND
This course is intended to help IND sponsors become familiar with applicable CMC statutes, regulations, and relevant documents.
- Electronic Common Technical Document (eCTD)
This course provides the essential steps of submitting electronic submissions to CDER, and can serve as a resource for questions about the submission process.
- Engaging with the FDA During New Drug Development
This course focuses on familiarizing small pharmaceutical business and industry in general with resources available to communicate with FDA, and provides guidance on effectively interacting with FDA throughout the new drug development process.
- Human Drug Establishment Registration and Drug Listing Compliance
This course identifies and discusses the statutory requirements regarding the submission of registration and drug listing information, and provides a clearer understanding of the registration and drug listing process.
Case Studies in FDA's Drug Regulatory Processes
For patients and patient advocacy groups, health professionals, small business, and pharmaceutical and clinical innovators designed to advance knowledge of drug regulatory processes. Each case study promotes active learning through exercises, instructor-led discussions, and quizzes.
A series of educational modules based on The CDER Forum for International Regulatory Authorities Lectures. The modules present an overview of the work of the Center for Drug Evaluation and Research.
The FDA Bad Ad Program and Prescription Drug Promotion
Credit is no longer available for this course.
This Web education course is designed to raise awareness among health care professionals (HCPs) about prescription drug promotion that may be misleading and educates HCPs about how to easily report these problems to FDA's Office of Prescription Drug Promotion.
Medicines in My Home -An Interactive Home
This educational program is designed to help consumers from adolescence to adulthood understand and use the Drug Facts label to choose over-the-counter medicines and use them safely.
- FDA Medwatch and Patient Safety
An online tutorial covering the MedWatch program goals of broadcasting safety information and encouraging adverse event reporting
- The FDA Process for Approving Generic Drugs
Credit is no longer available for this course.