This course, a Thomson Reuters Cortellis Regulatory Online Learning module, describes the regulatory requirements for the submission of investigational new drug (IND) applications in the United States. It explores the legal basis and framework, different types of INDs, roles of parties involved, content of the application, and benefits of pre-IND meetings. The course reviews how an IND application should be prepared for submission to the US Food and Drug Administration (FDA) review process. The course concludes by discussing outcomes of the FDA review process and strategies for maintaining and updating an effective IND.
- Regulatory requirements for the submission of IND applications in the United States
- Legal basis and framework, different types of INDs, roles of parties involved, content of the application, and benefits of pre-IND meetings
- Preparing and submitting an IND for FDA review
- Outcomes of FDA review process and how to maintain and update an effective IND
Who should attend?
Professionals and experts in the pharmaceutical, biotechnology, and medical device fields
Participants who complete this course should be able to:
- Understand the Investigational New Drug Application legislation
- Explain the roles of the parties involved in the IND application process
- Understand the purpose of Form FDA 1571
- Recognize the content of the application
- Understand the purpose of the pre-IND meeting
- Outline the IND application review process
- Understand the roles of the FDA Review Team members
- Recognize the different types of clinical holds
- List the grounds for the termination of an IND
- Understand the requirements for submitting amendments and reports
The course takes an average of 1.5 hours to complete.