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Drug Approval Primer

Drug Approval Primer offers a comprehensive overview of how small molecule drugs and biologics receive the regulatory green light for human use. With greater emphasis on the FDA, this class aims to demystify the game-changing Prescription Drug User Fee Act (PDUFA) and provide step-by-step guidance on the drug development application process. From the preclinical Investigational New Drug Application (IND) to the post-clinical New Drug Application (NDA) and Biologic License Applications (BLA), this primer covers each stage. It showcases the FDA meeting and response timeline, the tools used to enforce its laws, and strategies to expedite approvals for life-saving medicines. Acquire the regulatory knowledge needed to successfully navigate the drug approval process with the Drug Approval Primer class. Grab your spot today to gain insights into the process of bringing new drugs to market!

Section 1: Introduction to the Regulatory Process

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 an Investigational New Drug (IND) application and a Clinical Trial Application (CTA), discusses the components and timing of an IND application in the US, and lists the types of IND applications.

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 industry, and discusses how the EMA gives scientific advice to produce sponsors.

Section 4: Orphan Drugs and Expedited Pathways

Defines orphan diseases and discusses how this designation affects the regulatory process, explains breakthrough therapies and other FDA designations that accelerate the approval process, and summarizes an EMA expedited review.

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.

Five Takeaways


  1. Discuss the essential components and timing of Investigational New Drug (IND) applications in the United States and Clinical Trials Application (CTA) in the European Union.
  2. Explain the purpose and impact of the PDUFA legislation.
  3. Explore the criteria for various expedited drug approval pathways and how these designations can significantly speed up the timing of the regulatory process.
  4. Gain insight into the intricacies of filing for a New Drug Application (NDA) or Biologics License Application (BLA) in the United States and a Marketing Authorisation Application (MAA) in the European Union.
  5. Compare the approval pathways for generic drugs and biosimilars, highlighting each case’s unique considerations and challenges.


  • Closed Captioning in English, Spanish, French, French Canadian, Hindi, Japanese, Korean, Mandarin, Russian, Standard Arabic
  • Transcripts in English, Spanish, French, French Canadian, Hindi, Japanese, Korean, Mandarin, Russian, Standard Arabic
  • Course materials
  • Real-time tracking
  • Progress reporting
  • Accessibility features
  • Corporate account upgrades
  • LinkedIn certificate attachment
  • Verified certificates


  • How long do I have to complete an on-demand course?  You have one year from the date of purchase to complete the course. During that year, you may watch the class an unlimited number of times.
  • What happens if I don’t complete the course in one year?  There are no time extensions. If you want to complete the course, you must purchase it again.
  • How long are the on-demand classes?  Our longest course has a running time of 90 minutes. However, most have a running time of 45 minutes.  The running time is listed for each class on its registration page. The assessment at the end of each course takes between 10-20 minutes to complete.
  • Are there any downloadable class materials? No. All course slides and transcripts remain on your Biotech Primer dashboard, but they are always available for review.
  • What is the format of the on-demand classes?  The online class begins with the class objectives and the course itself and ends with a summary of what you learned. The course is a series of images and text accompanied by a professional voice-over and subtitles. Subtitles are available in 9 languages. The course ends with a quiz to assess your understanding.
  • Can I repeat the course?  You can repeat the course as often as you like within your one-year access.
  • How many times can I take the course quiz?  You have three chances to pass the quiz. A passing score is 75% or higher. You must pass the quiz to receive the class certificate. Your quiz score will be shown on your class certificate.
  • May I share a course I purchased with others?  Each course is to be taken by one individual. If you want to learn as a group, please contact us at for group pricing.

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