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.

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