How to Register a New Drug in the USA
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).
- 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
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.