FDA Regulation & Liability

 

Division of Online Learning

lawgrad@shu.edu | 973-642-8747

  • substantial equivalence
  • expanded access
  • biosimilars
  • preemption
  • pharmacovigilance
  • NDA
  • adverse events
  • warning letter
  • 510(k)
  • IND
  • REMS
  • breakthrough therapy

Learn to:

  1. Recognize the differences between the FDA’s approach to pre-market authorization of drugs, biologics, and devices

  2. Advise companies about their obligations to report on experiences with their products after they have entered the market

  3. Appreciate how the FDA enforces its regulatory requirements and the implications of enforcement mechanisms for individuals and companies

  4. Explain when state tort claims against drug and device manufacturers are preempted by federal law and when they are not


This pharmaceutical law course explores the FDA’s extensive regulation of the pharmaceutical and medical device industries, including the FDA approval process, pharmacovigilance, products liability and FDA preemption, FDA oversight of advertising and promotion, and life science companies and the First Amendment. Classroom exercises give students multiple opportunities to analyze new information and explain how it applies to real-world situations. Upon completion of the FDA law class, students will appreciate the scope of FDA regulations and implications of enforcement for companies in the pharmaceutical and medical device industries.


 


Graduate Programs Open House October 21, 2017. Learn more and register.



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compliance training and education
Health Law Publications