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Regulatory Affairs: The NDA Process: Requirements for Obtaining Approval for a New Drug in the USA (PRA07)

Certification Training Duration: 2 hours (the average time to complete the training program, including final assessments).
Credits Hours: 2
CPD Accredited TrainingAccreditation: This training course offers CPD accreditation from the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians.
CPD Credits: 3.5
Demonstration: Demo an online course.

Certificate: View sample certificate.

PRICE: USD $195.00 LogoTraining Program: Regulatory Affairs: The NDA Process: Requirements for Obtaining Approval for a New Drug in the USA
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Availability: Immediately available upon ordering.

Description: Online training with immediate access upon enrollment.

An NDA (New Drug Application) is a regulatory vehicle through which sponsors formally propose that the FDA approve a new drug for marketing and sale in the USA. For successful approval, what format and content requirements are needed in order to comply with guidelines set up by the FDA? How does one plan a submission timetable? This course provides answers to these questions, and will assist regulatory professionals with understanding the requirements to, not only complete NDA’s for approval by the FDA, but also how to submit them for approval.

This course includes a general overview, sessions on administrative information, statistical and clinical information, nonclinical information, CMC (chemistry, manufacturing, and controls) information, NDAs: content and formatting, accelerated approval options, NDA review and approval process, and a key point summary.

The entire program must be viewed by students in order to pass. An online, multiple-choice final assessment score of 80% or better is required. Course takers can attempt the final assessment any number of times, as needed, in order to achieve a passing grade of 80% or greater. Once all course requirements have been satisfied, a certificate of completion is immediately available.

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Should you have any particular question about this course, you can call us at (888) 111-1111 or send us an email at for more information.

Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with >80% passing grade within a 90 day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.

Online Training Programs Include:

  • Immediate access to training: Instructions, password, and username are emailed following order
  • 90 days of 24/7 access to individual training programs / 180 days for Professional Certification Program
  • Programs include voice-overs, easy navigation, progress checks, and high-quality animations
  • Course notes (in PDF) and/or references available with select training programs
  • Online final assessment with multiple-choice questions can be taken an unlimited number of times, until passing grade is achieved
  • A Certificate of Completion is immediately available once course requirements have been satisfied

The Regulatory Affairs: The NDA Process: Requirements for Obtaining Approval for a New Drug in the USA Course is Found in the Following Professional Certification Program(s):

International Regulatory Affairs Professional Certification Program: This professional certification program includes descriptions of the decentralized procedure (DCP), EU variations procedure, the mutual recognition procedure (MRP), the European centralized procedure (CP); requ … Learn more

Essentials in US Regulatory Affairs Professional Certification Program: This online professional certification program describes the essential requirements for obtaining approval of a new drug in the USA, the ‘NDA Process’. The program describes preparing submissions using the Comm … Learn more


Provided in this session is information on the module: the scope, the areas not covered, module objectives and US legislative framework. The background and history of NDAs is also included in this session.

NDAs: Content and formatting
This session provides an overview of the fundamental content and format requirements of an NDA for submission to the FDA. The four sessions that follow describe requirements for specific sections of the NDA.

Chemistry, Manufacturing and Controls (CMC) information
The CMC information that must be detailed in the application is described in this session.

Nonclinical information
The nonclinical information that must be detailed in an NDA is described in this session.

Clinical and statistical information
This session provides an overview of the content and format requirements of the NDAs clinical data section.

Administrative information
The content and format requirements of the index, labelling and application summary are addressed in this session.

NDA review and approval process
In this session, the review and approval process, and the FDA’s role and actions in it, are described.

Accelerated approval options
The FDA offers expedited approval programmes for drugs designed to treat serious or life-threatening conditions that demonstrate the potential to address unmet medical needs. These programmes are discussed in this session.

Key point summary
Key point summary for all topics covered in this module. Ideal for review, a refresher or consolidation of learning points.


Students completing this course should be able to:

–Outline the format and content requirements of a New Drug Application (NDA).

–Outline the necessary forms required for an NDA application.

–Review an NDA via a checklist prior to submitting it to the FDA.

–Summarize the role of the FDA in the NDA review and approval process.

–Define the programs implemented by the FDA to expedite the drug development and approval process.


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Clinical Research Regulatory Affairs Manager
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Posted Date: 2017-06-19
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Regulatory Reporting Specialist
Posted Date: 2017-06-23
COOK MEDICAL – United States, IN, Bloomington, 47404

Study Start Up Regulatory Submissions Coordinator
Posted Date: 2017-06-23
Medpace – United States, OH, Cincinnati, 45208

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