Prescription Drug Regulation, Cost, and Access: Current Controversies in Context offered by Harvard University
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Prescription Drug Regulation, Cost, and Access: Current Controversies in Context at Harvard University Overview
Prescription Drug Regulation, Cost, and Access: Current Controversies in Context
at Harvard University
Understand how the FDA regulates pharmaceuticals and explore debates on prescription drug costs, marketing, and testing.
Duration | 8 weeks |
Mode of learning | Online |
Difficulty level | Beginner |
Official Website | Go to Website  |
Course Level | UG Certificate |
Prescription Drug Regulation, Cost, and Access: Current Controversies in Context at Harvard University Highlights
Prescription Drug Regulation, Cost, and Access: Current Controversies in Context
at Harvard University
- Earn a certificate after completion of the course
Prescription Drug Regulation, Cost, and Access: Current Controversies in Context at Harvard University Course details
Prescription Drug Regulation, Cost, and Access: Current Controversies in Context
at Harvard University
Skills you will learn
What are the course deliverables?
- Key controversies over how prescription drugs are developed and marketed, and why those controversies exist
- The FDA its history, public health role, and rules affecting the US prescription drug market
- The process of discovering, testing, and approving innovative drugs, including various perspectives on the criteria used for drug approval
- The cost of prescription drugs, including the factors affecting a drug's market exclusivity period and the availability and use of affordable generic drugs
- Safety evaluation of prescription drugs using real world data
- Current debates over the scope of FDA regulation, such as dietary supplements, different special classes of prescription drugs, and right to try laws relating to experimental drugs with limited testing
More about this course
- Prescription drugs are among the most common health care interventions and have turned many once-fatal diseases into manageable conditions but they have also been a growing source of controversy. Patients and physicians in the US struggle with increasing costs and express concerns about why certain conditions like Alzheimer's disease remain without therapeutic options.
- At the center of these debates lies the US Food and Drug Administration (FDA), a federal agency responsible for monitoring the prescription drug marketplace and enforcing basic rules and laws that affect how prescription drugs are discovered, developed, and sold.
- In this course, we will investigate the major issues affecting the regulatory approval and evidence-based use of prescription drugs. You will understand the rules and regulations related to the pricing, marketing, and safety monitoring of approved prescription drugs and the importance of the FDA in regulating the pharmaceutical market.
- Medical professionals who enroll in the verified track and successfully complete Module 2: Drug Development and Approval can earn AMA PRA Category 1 CreditTM (2 credits).
Prescription Drug Regulation, Cost, and Access: Current Controversies in Context at Harvard University Curriculum
Prescription Drug Regulation, Cost, and Access: Current Controversies in Context
at Harvard University
Overview and history of the FDA
Drug development and approval
Drug pricing in the United States
Marketing strategies
Post-approval evaluation
Emerging medical technologies
Prescription Drug Regulation, Cost, and Access: Current Controversies in Context at Harvard University Faculty details
Prescription Drug Regulation, Cost, and Access: Current Controversies in Context
at Harvard University
Aaron Kesselheim
Designation : Associate Professor of Medicine, Director of the Program On Regulation, Therapeutics, And Law, Harvard University
Jonathan Darrow
Designation : Instructor in Medicine, Program On Regulation, Therapeutics, And Law, Harvard University
Ameet Sarpatwari
Designation : Instructor in Medicine, Assistant Director of the Program On Regulation, Therapeutics, And Law, Harvard University
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Prescription Drug Regulation, Cost, and Access: Current Controversies in Context at Harvard University Contact Information
Prescription Drug Regulation, Cost, and Access: Current Controversies in Context
at Harvard University
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