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  4. On Demand Webinar: What is new with Forms FDA 3542a and 3542?
  1. Development & Approval Process | Drugs

On Demand Webinar: What is new with Forms FDA 3542a and 3542?

This webinar describes the updates made to Forms FDA 3542a and 3542. An overview of the forms is provided as well as answers to frequently asked questions.

CDER Small Business and Industry Assistance Webinar Series

 

This on-demand webinar is FREE and posted in December 2019.

This webinar describes the updates made to Forms FDA 3542a and 3542. An overview of the forms is provided as well as answers to frequently asked questions.

ABOUT THIS WEBINAR

FDA walks participants through a mock form completion and address FAQs to ensure a thorough understanding of both the purpose and utility of the new Forms FDA 3542a and 3542.

LEARNING OBJECTIVES

  • 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

TARGET AUDIENCE

  • 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 to submit for submission of Forms FDA 3542 and 3542a 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

FDA SPEAKER

Alicia Chen, PharmD
Team Lead, Orange Book Staff Division of Legal and Regulatory Support (DLRS)
Office of Generic Drug Policy (OGDP) | Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER) | FDA

FDA RESOURCES

  1. Orange Book
  2. Code of Federal Regulations (CFR) Search
  3. FDA Forms

CONTACT

For questions concerning the webinar, please contact CDER SBIA at: CDERSBIA@fda.hhs.gov or call (866) 405-5367 | (301) 796-6707

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