Continuing Education Credit for this activity is no longer available.
About this site:
This activity is supported by the US Food and Drug Administration (FDA) through a contract from the Department of Health and Human Services, and FDA's privacy policies apply while you are on this site.
Continuing Education Credits (CE) Released: 2/25/2016; Valid for credit through: 7/31/2019
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
Nurse Practitioners – 1.5 AANP Contact Hours
Physician Assistants – 1.5 hours of Category 1 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 healthcare 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 explains how U.S. public health policy has influenced and shaped the Food and Drug Administration (FDA) protections that Americans have come to expect, provides an overview of FDA's Center for Drug Evaluation and Research, or CDER's, role in the regulation of new drug development, marketed drugs, quality testing, and post-market surveillance, and identifies new directions for the human drug regulatory process in the United States.
Learning Objectives:
Upon completion of this activity, participants should be able to:
- Describe and explain the drug development and review process in the United States for new drugs, generics, over-the-counter (OTC) drugs, and biosimilars.
- Outline CDER's role in post-marketing safety surveillance for medical products.
- Identify ways CDER disseminates safety information about medical products to both health care professionals and their patients.
- Describe CDER initiatives and commitments for the protection of public health.
- Describe the new drug development and review process.
Pharmacy Technician Learning Objectives:
Upon completion of this activity, participants should be able to:
- State the mission of CDER.
- Describe the drug development and review process in the United States for new drugs, generics, over-the-counter (OTC) drugs, and biosimilars.
- Discuss how CDER functions to ensure drug and medical product safety post-marketing and protection of public health.
- Identify ways CDER disseminates safety information about medical products to both health care professionals and their patients.
- Describe how to report an adverse drug event or a marketed medical product problem to the FDA using the MedWatch program.
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.
| Person | Role | Relationship |
|---|---|---|
| Elaine Frost | Planner | NA |
| Joseph Cheek | Planner | NA |
| Kimberly Chiu | Planner, Reviewer | NA |
| Renu Lal | Planner, Reviewer | NA |
Accreditation Statement:
In support of improving patient care, this activity has been planned and implemented by Amedco LLC and the US 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 healthcare 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.
For Nurse Practitioners:
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.
For Physician Assistants:
AAPA accepts AMA PRA Category 1 Credit(s)™ for the PRA from organizations accredited by ACCME.
Method of Physician Participation:
Each participant will listen to each audio self-directed module while following along with the visual slides. Upon completion, each physician will answer evaluation questions and pass a posttest with at least a score of 80% to receive their CE/CME certificate.
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 posttest. To receive your certificate for CE credit, you must complete the posttest and receive a score of 80 percent 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