BIO Professional Development

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The Regulatory Process

The Regulatory Process provides a summary of the regulatory bodies involved in approving both small molecule drugs and biologics. Understand the application process involved in moving a drug candidate from preclinical studies in animals to human clinical studies, to final approval allowing for marketing and sale of a drug product. Learn the ways a drug candidate approval can be expedited so life saving medicines can get to patients faster. Familiarize yourself with the US Prescription Drug User Fee Act (PDUFA) which governs it all. The Regulatory Process class gives an overview of all regulatory considerations a drug manufacturer should take into account as it seeks to prove their drug is safe and effective.

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The Regulatory Process Course Trailer


  • Discuss the components and timing of an Investigational New Drug (IND) application for the United States and a Clinical Trials Application (CTA) for the European Union.
  • Explain the purpose of the Prescription Drug User Fee Act of 1992 (PDUFA) and how it is a win/win for both the drug manufacturers, the FDA and patients.
  • Understand the criteria of various expedited drug approval pathways (including orphan designation) and discuss how these designations effect the timing of the regulatory process.
  • Describe the process of filing for either New Drug Application (NDA) of Biologics License Application (BLA) in the US.
  • Compare and contrast generics and biosimilar approval pathways.

Download Course Syllabus

The Regulatory Process
Course Price:
$150 USD
BIO Member Price:
$120 USD
Course Length:
60 minutes
Course Level:
Completion Period:
2 weeks
Course Format:

Certificate Requirements

  • View the entire course
  • Pass the course exam with a 70 percent
  • Complete the course evaluation
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