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How to Register a New Drug in the USA

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This course, a Thomson Reuters Cortellis Regulatory Online Learning module, describes how to register a drug through the new drug application (NDA) process administered by the Center for Drug Evaluation and Research (CDER). The course outlines submission requirements and document preparation steps. It concludes with an in-depth analysis of the NDA review process and sponsors’ opportunity for interaction with the US Food and Drug Administration (FDA).

Featured Topics 

  • NDA process under the CDER
  • NDA review process and the FDA

Who Should Attend 

Professionals and experts in the pharmaceutical, biotechnology, and medical device fields

Learning Objectives 

Participants who complete this course should be able to:

  • Explore the new drug development cycle phases
  • Identify the acts that provide the legal basis for NDAs
  • Explain CDER's role and responsibility in the drug approval process
  • Examine the content and format of an application.
  • Recognize the elements of a RiskMAP
  • Clarify the types and purposes of the PDUFA fees
  • Review new drugs’ patent life and exclusivity
  • Differentiate between the various reviews conducted by the FDA
  • Discuss the possible outcomes of the review process

The module takes an average of 1.5 hours to complete.

Contact Information 

Linda Belmont, DIA
Phone +

Technical Requirements 

Click here for minimum system requirements.

Registration Fees 

Other Fees

Register Online

Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.

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