FDA's Role in Public Health:
Drug Efficacy, Safety, Quality, and Beyond
About this site:
This activity is supported by the U.S. Food and Drug Administration (FDA) through a contract from the the U.S. Department of Health and Human Services, and FDA's privacy policies apply while you are on this site.
Target Audience:
The target audience for this course is health care professionals, including physicians, physician assistants, nurses, nurse practitioners, pharmacists, and pharmacy technicians.
Description:
This activity will educate a national audience of health care providers about the basics of the FDA drug regulatory process and the science that supports this mission in CDER. It will also educate the nation's health care providers about their role in communicating drug information to their patients.
Learning Objectives:
Upon completion of this activity, participants should be able to:
- Describe and explain the drug development and assessment process in the United States for new drugs, therapeutic biologic drugs, generic drugs, biosimilars and over-the-counter (OTC) drugs.
- Outline CDER's role in post-marketing safety surveillance for medical products.
- Identify ways CDER disseminates safety information to both health care professionals and their patients.
- Describe CDER initiatives and commitments for the protection of public health.
Acknowledgement of Financial Commercial Support:
No commercial support was received for this educational activity.
Acknowledgement of In-Kind Commercial Support:
No in-kind commercial support was received for this educational activity.
Disclosure Information
The following table of disclosure information is provided to learners and contains the relevant financial relationships that each individual in a position to control the content of the course. All of these relationships were treated as a conflict of interest and have been resolved. (C7 SCS 6.1--6.2, 6.5).
All individuals in a position to control the content of the course are listed below and had no relevant financial relationship to disclose.
| First Name | Last Name | Disclosure |
|---|---|---|
| Elaine | Frost | Nothing to disclose |
| Mary | Kremzner | Nothing to disclose |
| Renu | Lal | Nothing to disclose |
| Rachel | Shaw | Nothing to disclose |
| Victoria | Wilson | Nothing to disclose |
Handouts and Resources:
Technical Requirements and Instructions:
To access the course, users will need a computer with an Internet connection, and:
- Internet Explorer 10 or higher,
- Firefox 43 or higher,
- Safari 9 or higher, or
- Any other W3C standards compliant browser
An HTML5 capable browser is required for video playback. Occasionally, other additional software may be required such as PowerPoint or Adobe Acrobat Reader. Viewing on a desktop, laptop or tablet is recommended.
For questions about content or about technical issues, you may contact FDA:
Toll Free
(855) 543-3784, or
(301) 796-3400
druginfo@fda.hhs.gov