Division of Clinical Research

Office of the Vice President and Innovation

A free On-Demand Webinar is available for viewing that addresses updates made to Forms FDA 3542a and 3542. An overview of the forms is provided as well as answers to frequently asked questions.

Link: www.fda.gov/drugs/development-approval-process-drugs/demand-webinar-what-new-forms-fda-3542a-and-3542?utm_campaign=CDERSBIA%20Webinar%3A%20Form%203542&utm_medium=email&utm_source=Eloqua

This webinar describes the recent updates made to Forms FDA 3542a and 3542, which NDA applicants holders use to submit patent information to FDA. The updates we made are intended to:

  • reduce time to complete and process forms,
  • update certain form fields to prevent common errors, and
  • provide technical fixes to streamline form completion.

In addition to explaining these changes, the webinar will provide you with an in-depth overview of the forms and answers to commonly asked questions.


  • NDA Applicants and Holders who have eligible patents for listing in the Orange Book
  • Patent owners, regulatory affairs professionals, and consultants who submit or assist NDA applicants and holders with the submission of Forms FDA 3542a and 3542 for New Drug Applications (NDAs)
  • Regulatory professionals who would like to understand more about how Forms FDA 3542a and 3542 are used by industry and the FDA


  • Introduction to Forms FDA 3542a and 3542
  • Walk-through of Form 3542
  • Frequently asked questions


  • Explain the purpose of the Forms FDA 3542a and 3542
  • Describe the rationale behind the recent changes made to the Forms FDA 3542a and 3542
Categories FDA Regulatory
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