The Regulatory Process for Drug Approval

  • Course Price: $150 USD
  • BIO Member Price: $120 USD
  • Course Run Time: 60 minutes
  • Course Level: Level 1 - Foundational
  • Completion Period: 2 week

The Regulatory Process for Drug Approval summarizes 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 the marketing and sale of a drug product. Learn how 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 for Drug Approval gives an overview of all regulatory considerations a drug manufacturer should consider as it seeks to prove its drug is safe and effective.

Takeaways
  1. 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.
  2. Explain the purpose of the Prescription Drug User Fee Act of 1992 (PDUFA) and how it is a win/win for drug manufacturers, the FDA, and patients.
  3. Understand the criteria of various expedited drug approval pathways and discuss how these designations affect the timing of the regulatory process.
  4. Describe the process of filing for a New Drug Application (NDA) or Biologics License Application (BLA) in the United States and the Marketing Authorisation Application (MAA) in the European Union.
  5. Compare and contrast generics and biosimilar approval pathways.
Certificate Requirements
  • View entire course.
  • Pass course exam with a 70 percent
Download Agenda
Certificate Requirements
  • View entire course.
  • Pass course exam with a 70 percent
Trailer
Section 1: Introduction
Describes the organization and mission of the FDA and EMA and discusses the global harmonization of drug testing requirements.
Section 2: IND/CTA Filing
Defines and Investigational New Drug (IND) application and a Clinical Trial Application (CTA), discusses the components and timing of and IND applicat...More
Section 3: User Fee Programs
Defines the Prescription Drug Fee User Act (PDUFA), lists the purpose and timing of FDA formal meetings and other tools the FDA uses to interact with...More
Section 4: Orphan Drugs and Expedited Pathways
Defines orphan diseases and discusses how this designation effects the regulatory process, explains breakthrough therapies and other FDA designations...More
Section 5: Market Approval
Describes the process of a New Drug Application (NDA) in the US, lists the different paths to approval in the EU, and describes generics and biosimilars approval pathways.
Final Quiz
LinkedIn Certificate Demo
Certificate Requirements
  • View entire course.
  • Pass course exam with a 70 percent