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Course # 95000 • Expanding the Options: The Drug-Approval Process in the United States

Overview

The U.S. Food and Drug Administration (FDA) regulates many products, but despite the agency's expansive reach, many healthcare professionals may be unfamiliar with what the FDA regulates and how it determines whether a drug is approved, as well as the processes and standards for drug approval. This course aims to educate physicians and other healthcare professionals who prescribe drugs on how the FDA ensures the safety, efficacy, and security of these products. Participants will learn the regulatory considerations for how clinical trials are designed and conducted, as well as the general criteria for how new drugs are developed, tested, approved, and monitored. This course covers only products regulated by the FDA's Center for Drug Evaluation and Research (CDER).

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Education Category: Pharmacology

Release Date: 08/01/2020

Expiration Date: 07/31/2023

Audience

This course is designed for all physicians, pharmacy professionals, and nurses involved prescribing and/or administering medications.

Accreditations/Approvals

In support of improving patient care, NetCE 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. NetCE is accredited by the International Association for Continuing Education and Training (IACET). NetCE complies with the ANSI/IACET Standard, which is recognized internationally as a standard of excellence in instructional practices. As a result of this accreditation, NetCE is authorized to issue the IACET CEU.

Designations of Credit

This activity was planned by and for the healthcare team, and learners will receive 5 Interprofessional Continuing Education (IPCE) credit(s) for learning and change. NetCE designates this enduring material for a maximum of 5 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. NetCE designates this continuing education activity for 5 ANCC contact hour(s). NetCE designates this continuing education activity for 6 hours for Alabama nurses. NetCE designates this activity for 5 ACPE credit(s). ACPE Universal Activity Number: JA4008164-0000-20-079-H04-P. Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to 5 MOC points in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for the activity. It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. Completion of this course constitutes permission to share the completion data with ACCME. Successful completion of this CME activity, which includes participation in the evaluation component, enables the learner to satisfy the Lifelong Learning, Self-Assessment, Improvement in Medical Practice and/or Patient Safety requirements for the American Board of Ophthalmology's Maintenance of Certification program. It is the CME activity provider's responsibility to submit learning completion information to ACCME for the purpose of granting MOC credit. NetCE is authorized by IACET to offer 0.5 CEU(s) for this program. AACN Synergy CERP Category B.

Individual State Nursing Approvals

In addition to states that accept ANCC, NetCE is approved as a provider of continuing education in nursing by: Alabama, Provider #ABNP0353, (valid through November 21, 2021); Arkansas, Provider #50-2405; California, BRN Provider #CEP9784; California, LVN Provider #V10662; California, PT Provider #V10842; District of Columbia, Provider #50-2405; Florida, Provider #50-2405; Georgia, Provider #50-2405; Kentucky, Provider #7-0054 through 12/31/2021; South Carolina, Provider #50-2405; West Virginia RN and APRN, Provider #50-2405.

Special Approvals

This activity is designed to comply with the requirements of California Assembly Bill 1195, Cultural and Linguistic Competency.

Course Objective

The purpose of this course is to educate physicians and other healthcare professionals who prescribe drugs on how the FDA ensures the safety, efficacy, and security of approved products.

Learning Objectives

Upon completion of this course, you should be able to:

  1. Outline the background and process of drug approval in the United States.
  2. Describe aspects of the approval and post-approval phase of drug development in the United States, including programs that improve access.
  3. Outline the steps of drug development and approval.
  4. Differentiate the FDA's expedited new drug review pathways.
  5. Describe the post-approval responsibilities of the FDA, manufacturers, and prescribers.
  6. Explain expanded access, rare disease development, and orphan drug development.

Faculty

John J. Whyte, MD, MPH, is currently the Director of Professional Affairs and Stakeholder Engagement at the FDA's Center for Drug Evaluation and Research. Previously, Dr. Whyte served as the Chief Medical Expert and Vice President, Health and Medical Education at Discovery Channel, part of the media conglomerate Discovery Communications. In this role, Dr. Whyte developed, designed, and delivered educational programming that appeals to both a medical and lay audience.

Prior to this, Dr. Whyte was in the Immediate Office of the Director at the Agency for Healthcare Research Quality. He served as Medical Advisor/Director of the Council on Private Sector Initiatives to Improve the Safety, Security, and Quality of Healthcare. Prior to this assignment, Dr. Whyte was the Acting Director, Division of Medical Items and Devices in the Coverage and Analysis Group in the Centers for Medicare & Medicaid Services (CMS). CMS is the federal agency responsible for administering the Medicare and Medicaid programs. In his role at CMS, Dr.Whyte made recommendations as to whether or not the Medicare program should pay for certain procedures, equipment, or services. His division was responsible for durable medical equipment, orthotics/prosthetics, drugs/biologics/therapeutics, medical items, laboratory tests, and non-implantable devices. As Division Director as well as Medical Officer/Senior Advisor, Dr. Whyte was responsible for more national coverage decisions than any other CMS staff.

Dr. Whyte is a board-certified internist. He completed an internal medicine residency at Duke University Medical Center as well as earned a Master’s of Public Health (MPH) in Health Policy and Management at Harvard University School of Public Health. Prior to arriving in Washington, Dr. Whyte was a health services research fellow at Stanford and attending physician in the Department of Medicine. He has written extensively in the medical and lay press on health policy issues.

Junyang Wang, MSc, is a Clinical Analyst in Professional Affairs and Stakeholder Engagement at the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration. In this role, Mr. Wang works closely on issues of demographic subgroup analyses, variability to drug response, and the Drug Trials Snapshots transparency initiative. He has led large data science projects combining patient demographic data with clinical trial site geographic data to better understand the global make-up of clinical trials across the world. Previously, Mr. Wang worked for the Public Relations firm Edelman in Los Angeles, conducted health economic research at the National University of Singapore, and assisted in developing the new Duke-Kunshan University in Kunshan, China. He completed his Masters of Science in Global Health as well as a Bachelor’s of Science in Psychology from Duke University.

Noah Goetzel, is a Master of Public Health (MPH) candidate at the Columbia University Mailman School of Public in the Health Promotion Research and Practice certificate program and earned his Bachelor of Arts degree in Journalism and Radio, TV, and Film Studies at the University of Wisconsin-Madison. He is studying the intersection between health behavior change theory and communication campaign planning in the digital age. His thesis project evaluates the effectiveness of the Health Mentorship program at EHE Health in helping patients achieve their weight loss, nutrition, physical activity, stress management, sleep, and substance use goals. As a creative intern at EHE Health, Mr. Goetzel leads a study measuring the impact of wearable posture trainer biofeedback devices on musculoskeletal symptoms, manages EHE Health’s social media accounts, and leads patient health incentive implementation efforts. Prior to his internship, Mr. Goetzel was a liaison between clinical drug reviewers and patient and professional group stakeholders as an ORISE Fellow at the U.S. Food and Drug Administration (FDA).

Faculty Disclosure

Contributing faculty, John J. Whyte, MD, MPH, has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

Contributing faculty, Junyang Wang, MSc, has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

Contributing faculty, Noah Goetzel, has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

Division Planners

John M. Leonard, MD

Jane C. Norman, RN, MSN, CNE, PhD

Randall L. Allen, PharmD

Division Planners Disclosure

The division planners have disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

About the Sponsor

The purpose of NetCE is to provide challenging curricula to assist healthcare professionals to raise their levels of expertise while fulfilling their continuing education requirements, thereby improving the quality of healthcare.

Our contributing faculty members have taken care to ensure that the information and recommendations are accurate and compatible with the standards generally accepted at the time of publication. The publisher disclaims any liability, loss or damage incurred as a consequence, directly or indirectly, of the use and application of any of the contents. Participants are cautioned about the potential risk of using limited knowledge when integrating new techniques into practice.

Disclosure Statement

It is the policy of NetCE not to accept commercial support. Furthermore, commercial interests are prohibited from distributing or providing access to this activity to learners.

Technical Requirements

Supported browsers for Windows include Microsoft Internet Explorer 9.0 and up, Mozilla Firefox 3.0 and up, Opera 9.0 and up, and Google Chrome. Supported browsers for Macintosh include Safari, Mozilla Firefox 3.0 and up, Opera 9.0 and up, and Google Chrome. Other operating systems and browsers that include complete implementations of ECMAScript edition 3 and CSS 2.0 may work, but are not supported. Supported browsers must utilize the TLS encryption protocol v1.1 or v1.2 in order to connect to pages that require a secured HTTPS connection. TLS v1.0 is not supported.

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