Submitting a New Drug Application (NDA) in the USA

Master the complexities of the New Drug Application (NDA) process in the USA. This certified course offers a clear breakdown of submission requirements, providing practical strategies (what to submit, how to format it, and how the review process works) to ensure compliance and streamline each stage of the process to obtain a drug approval in the USA. 

Who should enroll?

This course is designed for regulatory affairs professionals, quality assurance specialists, pharmaceutical project managers, and product development teams. It’s ideal for those preparing NDAs for FDA submission or anyone seeking to understand the US regulatory framework for new drugs.

Topics outlined in the course:

• Key requirements for NDA submission and regulatory timelines.
• Structuring and preparing the Common Technical Document (CTD).
• Navigating FDA interactions, including pre-submission meetings.
• Strategies for handling post-submission queries and amendments.
• Ensuring compliance with clinical, nonclinical, and manufacturing sections.

Each session includes real-world examples and assessments for practical, applied learning. Upon completion, participants receive a globally recognized certificate, traceable and valid for audits.

Curriculum:

Introduction

Lesson 1: Overview of NDA

Lesson 2: Content and Format of NDA

Lesson 3: Administrative Information (Module 1)

Lesson 4: Common Technical Document Summaries (Module 2)

Lesson 5: Quality Information (Module 3)

Lesson 6: Non-Clinical Study Reports (Module 4)

Lesson 7: Clinical Study Reports (Module 5)

Lesson 8: NDA Review and Approval Process

Conclusion

Assessment