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.

  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
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
You have two weeks from time of purchase to complete any of the online courses. For example, if you purchase the course at 9 am on Saturday, the course will close at 9 am 14 days later.

Our online classes are between 40 minutes and 85 minutes in length. We suggest allowing 20 minutes to take the end of the course quiz and 10 minutes to complete the class evaluation. 

Yes, each course has an accompanying pdf that contains all of the presented course information. 

There are no refunds once you have purchased an online course. 

The online classes are fully animated with a professional voice-over. Each course begin with an overview of what you will learn, the course itself, and then ends with a course quiz to assess your understanding.

You can repeat the class as often as you like within your two week run time.

You have two chances to pass the quiz. A passing score is 70% or higher. 

Each course is to be taken by one individual. If you would like to take our online courses as a group, please contact Stacey Hawkins at This email address is being protected from spambots. You need JavaScript enabled to view it. for pricing.

There are three requirements to receive your course certificate.

  1. You must view the entire course.
  2. You must pass the course quiz with a 70%.
  3. You must complete the course evaluation.

You can download and print your certificate from your dashboard only when all three of these items are completed. 

Before moving on to the next section of our on-demand, online courses, all slides within a section must be viewed.

There is an easy way for you to see which slides you have completed and not completed in the course. Look at the menu on the left side of the course- the slides that have been seen are darkened and the slides that have not been seen are light. 


BIO member discounts are available for on-demand, online classes. To access the BIO member discount, use your company email address during the checkout process. The checkout system will automatically recognize your organization and apply the 20% discount to your purchase if your company is a member of BIO. If you use a private email address we are unable to provide you the BIO membership discount.

If your on-demand course expires, but you have not completed it, you can extend it for an additional 2 weeks for $25.

  • Log into your dashboard
  • Go to the on-demand course you want to extend
  • The "Course Extension" button brings you to the payment gateway
  • Please note: It will appear you are being asked to pay the full amount of $150, but a discount will be automatically given once you fill in all of your payment information. 

You have 90 days, from the day your course expires, to take advantage of this nominal extension fee. Once the 90 days are past, you will need to pay the full price to view the course again. 

  1. Once your online course starts click on “Resources” in the upper right-hand corner
  2. In the drop down menu find the link “Course Slides”
  3. Download and/or print 
Certificate Requirements
  • View entire course.
  • Pass course exam with a 70 percent