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.
Continuing Education Credits (CE) Released: 06/07/2021; Valid for credit through: 06/07/2024
Credits Available:
Physicians – 1.5 AMA PRA Category 1 Credit(s)™Nurses – 1.5 ANCC Contact Hours
Pharmacists and Pharmacy Technicians – 1.5 ACPE Contact Hours
Physician Assistants – 1.5 hours of Category I Credit
Certificates of Completion:
For users wishing to have confirmation that they have completed this course, they may choose to receive a Certificate of Completion which comes with no CE credits.
Target Audience:
The target audience for this course is health care professionals, including physicians, physician assistants, nurses, nurse practitioners, pharmacists, and pharmacy technicians. The course can be taken for informational purposes or for Continuing Education (CE) credit.
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 CME disclosed to Amedco. 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 CE/CME 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:
Accreditation Statement:
In support of improving patient care, this activity has been planned and implemented by Amedco LLC and the U.S. Food and Drug Administration (FDA). Amedco LLC is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the health care team.
Physician Credit Designation Statement:
Amedco LLC designates this enduring material for a maximum of 1.5 AMA PRA Category 1 Credit(s)™ for physicians. Learners should claim only the credit commensurate with the extent of their participation in the activity.
Nurse Credit Designation Statement:
Amedco LLC designates this enduring material for a maximum of 1.5 contact hours for nurses. Learners should claim only the credit commensurate with the extent of their participation in the activity.
Pharmacist and Pharmacy Technician Credit Designation Statement:
Amedco LLC designates this enduring material for a maximum of 1.5 knowledge-based contact hours for pharmacists. Learners should claim only the credit commensurate with the extent of their participation in the activity.
NOTE to Pharmacists and Pharmacy Technicians: The only official Statement of Credit is the one you pull from CPE Monitor. You must request your certificate within 30 days of the activity to meet the deadline for submission to CPE Monitor. If you do not see your credits on CPE Monitor within 45 days, please reach out to your program sponsor as there is a strict 60-day limit on uploading credits.
Nurse Practitioner Credit Designation Statement:
The American Association of Nurse Practitioners (AANP) recognizes the Accreditation Council for Continuing Medical Education (ACCME) and the American Nurses Credentialing Center (ANCC) as approved accreditors and allow reciprocity for AANPCP continuing education credit.
Physician Assistant Credit Designation Statement:
Amedco has been authorized by the American Academy of PAs (AAPA) to award AAPA Category 1 CME credit for activities planned in accordance with AAPA CME Criteria. This activity is designated for 1.5 AAPA Category 1 CME credits. Approval is valid until June 7, 2024. PAs should only claim credit commensurate with the extent of their participation.
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.
Users are required to visit all screens before getting access to the Conclusion module and the post-test. To receive your certificate for CE credit, you must complete the post-test and receive a score of 80% or better and complete an evaluation form.
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