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308.616.13
Regulation of Prescription Drugs & Biologics by the U.S. Food & Drug Administration

Location
East Baltimore
Term
Winter Institute
Department
Health Policy and Management
Credit(s)
2
Academic Year
2017 - 2018
Instruction Method
TBD
Start Date
Thursday, January 11, 2018
End Date
Friday, January 12, 2018
Class Time(s)
Th, F, 9:00am - 5:30pm
Auditors Allowed
No
Available to Undergraduate
No
Grading Restriction
Letter Grade or Pass/Fail
Course Instructor(s)
Contact Name
Frequency Schedule
One Year Only
Next Offered
Only offered in 2017
Description
How does a start-up biotech company deal with FDA? Should seriously ill patients have access to unapproved drugs or biologics that might extend their lives? Why are there delays in FDA approval of some generic drugs? How does FDA go about deciding whether Americans should have access to a new drug—or not?
Reviews FDA’s regulation of prescription drugs and biologics. Discusses the relevant parts of the Food Drug & Cosmetic Act and FDA’s regulations. Includes the development of drugs and biologics from preclinical studies to investigational new drug status to post-approval (‘Phase IV’) studies. Discusses generic drugs, orphan drugs, and biosimilars. Examines ‘market exclusivity.’ Explores the public debate on ‘compassionate use’ of unapproved drugs and biologics. Introduces whether FDA should continue to withhold from public disclosure clinical data submitted to support the approval of drugs and biologics.
Learning Objectives
Upon successfully completing this course, students will be able to:
  1. Explain the stages of FDA’s approval and post-approval processes for drugs and biologics
  2. Critique FDA’s approach to generic drugs, orphan drugs, and biosimilars
  3. Identify the triggers for granting market exclusivity to a drug or biologic
  4. Link public health concerns with FDA’s ‘compassionate use’ policies
  5. Analyze FDA’s withholding of clinical trial data
Enrollment Restriction
Students who completed the special studies version of this course (302.841.51) should not take this course.
Special Comments

Students are expected to participate in class discussions, presentations, and complete all assigned readings prior to the course. The final written policy analysis assignment will be due no later than February 2, 2018.