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The FDA and Prescription Drugs: Current Controversies in Context

Harvard University via edX

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Overview

Prescription drugs are among the most common health care interventions and have turned some once-fatal diseases into manageable conditions — but they have also been a growing source of controversy. Patients in the US struggle with increasing costs and express concerns about why many conditions, such as Alzheimer’s disease, remain without adequate 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.

This course investigates the major issues affecting the regulatory approval and evidence-based use of prescription drugs. You will learn the rules and regulations governing the pricing, marketing, and safety monitoring of approved prescription drugs and the importance of the FDA in regulating key aspects of the pharmaceutical market.

Syllabus

  • Module 1: Overview and history of the FDA
  • Module 2: Drug development and approval
  • Module 3: Drug pricing in the United States
  • Module 4: Marketing strategies
  • Module 5: Post-approval evaluation
  • Module 6: Emerging medical technologies

Taught by

Aaron Kesselheim, Jonathan Darrow and Ameet Sarpatwari

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