340.622.79
FDA's Regulation of Prescription Drug Safety and Effectiveness
Location
Internet
Term
Summer Institute
Department
Epidemiology
Credit(s)
2
Academic Year
2026 - 2027
Instruction Method
Online Synchronous (at least one synch session/week)
Start Date
Monday, June 22, 2026
End Date
Friday, June 26, 2026
M, Tu, W, Th, F, 8:30am - 12:00pm
Auditors Allowed
No
Available to Undergraduate
No
Grading Restriction
Letter Grade or Pass/Fail
Course Instructor(s)
Kevin Fain
Contact Name
Frequency Schedule
Every Year
Resources
Prerequisite
Basic epidemiology and biostatistics
Enrollment Restriction
This course is not restricted.
The safety and efficacy of prescription drugs is critical for the prevention and treatment of diseases and health conditions. The U.S. Food and Drug Administration (FDA) has substantial regulatory oversight over prescription drugs and makes decisions about whether to approve a drug based on the epidemiologic evidence and relevant legal standards. These decisions have significant implications for patients, healthcare professionals, and public health. This course is intended to help public health professionals understand how FDA determines whether to approve a prescription drug as safe and effective and the epidemiologic evidence underlying these FDA determinations.
Reviews regulatory standards and how FDA evaluates epidemiologic evidence to assess a drug’s efficacy and safety. Examines the quality and quantity of epidemiologic evidence needed to demonstrate substantial evidence of effectiveness for a drug and how FDA assesses and balances the drug’s harms and risks based on the relevant evidence. Reviews the accelerated approval pathway as a regulatory option for a drug’s approval, and how FDA applies this pathway based on the epidemiologic evidence. Assesses case studies of FDA actions applying these methods of assessment and standards.
Learning Objectives
Upon successfully completing this course, students will be able to:
- Identify the regulatory framework for FDA’s oversight of prescription drugs, particularly the drug approval standard and how FDA evaluates the epidemiologic evidence for a drug’s efficacy and safety.
- Recognize and critically evaluate how FDA assesses epidemiologic evidence of a drug’s efficacy, particularly to determine whether there is substantial evidence of effectiveness under the regulatory standard.
- Recognize and critically evaluate how FDA assesses epidemiologic evidence of a drug’s safety and weighs the evidence of a drug’s harm against the drug’s benefit to determine whether the drug can be approved under the regulatory standard.
- Recognize and critically evaluate how FDA applies regulatory flexibility in making determinations about whether a drug can be approved, particularly in assessing the drug’s efficacy and the weighing of the drug’s benefits and risks.
- Identify the accelerated approval pathway as an option for a drug’s approval and critically evaluate how FDA determines whether the epidemiologic evidence is appropriate for this pathway and sufficient for the drug’s approval.
Upon successfully completing this course, students will be able to:
Methods of Assessment
This course is evaluated as follows:
- 67% Assignments
- 33% Final Paper