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The FDA and Prescription Drugs: Current Controversies in Context

The FDA and Prescription Drugs: Current Controversies in Context

Understand how the FDA regulates pharmaceuticals and explore debates on prescription drug costs, marketing, and testing


Course Highlights

  • The self-paced nature of the course will allow learners to access it at their convenience

  • This course is offered by HARVARD University

  • Add a Verified Certificate for ?7,132

  • It is Completely a FREE Course

Duration: 56 Days

Mode of learning: Online self study

Course Overview

Who should do this course ?
  • Medical professionals who enroll in the verified track and successfully complete Module 2: Drug Development and Approval can earn AMA PRA Category 1 Credit™ (2 credits).

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

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