For Health Professionals

FDA Case Studies

screenshots of FDA Case StudiesEach case study promotes active learning through exercises, instructor-led discussions, and quizzes. Designed as a fictional case study based on a real-world scenario, the curriculum follows a format similar to Harvard Business Review Case Studies and builds on previous case studies.

Case study and instructor guide files are available below in PDF format. Case studies and instructor guides are available for anyone to use. However, FDA is not responsible for changes or modifications made to the published PDF documents on the FDA web site. 

FDA MedWatch Adverse Event Reporting - Case Study

This case study teaches students and health professionals how to complete the forms necessary to report problems to FDA. Additionally, the MedWatchLearn tool gives students and health professionals the opportunity to practice filling out FDA Form 3500 (for health professionals) or FDA Form 3500B (for consumers) online.

Health professionals encounter adverse events with medical products and learn about reporting to FDA MedWatch. This case study has the following learning objectives:

  • Identify how to receive safety information from the FDA.
  • Identify how to submit a quality medical product problem report to FDA.
  • Explain how reports are used by FDA to investigate medical product problems and are translated into safety actions such as recalls or safety communications.
  • Review the definitions of drug, device, and biologic.

Instructor’s guide - MedWatch Case Study


Useful FDA Drug Information for Clinicians - Case Study

Practicing clinicians seek available information on a new drug before making a treatment decision. This case study has the following learning objectives:

  • Identify an online resource for FDA’s drug review materials found at:
  • Determine if a drug or biologic marketed in the U.S. has been discussed at an FDA advisory committee meeting.
  • Gain an understanding of the FDA advisory committee’s evaluation of a product’s benefits and risks.
  • Explain the characteristics of a new molecular entity (NME).
  • Gain an understanding of Risk Evaluation and Mitigation Strategies (REMS) and their role.

Instructor’s guide - Useful FDA Drug Information for Clinicians

A Note From the Program Director

"These studies can be integrated into the curriculum at colleges that educate health professionals (e.g. schools of nursing, medicine, pharmacy, biomedical engineering).  The goal of the first case study is to develop a culture of safety, accountability and shared responsibility in these students before they begin working with patients in the clinical setting. The second case study highlights FDAs available resources that practicing clinicians can refer to for medical product information”.  - Anna Fine, PharmD 

Cristina Klafehn, PharmD, BCPS, CDE

Please direct comments on the case studies to:

Cristina Klafehn, PharmD, BCPS, CDE
Health Programs Coordinator
Office of Health & Constituent Affairs



Other FDA Case Studies

Page Last Updated: 03/27/2018
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