The New Drug Application (NDA) for Marketing Approval in the USA

Thu 11 Jul 2013 @ 11:01

Zenosis, the leading provider of specialized training solutions for the pharmaceutical industry has announced the release of a new e-course, The NDA Process: Requirements for Obtaining Approval for a New Drug in the USA

  • A fresh new interface
  • Audio support with animation
  • Immersive activities throughout

A New Drug Application (NDA) is a regulatory vehicle through which Sponsors formally propose that the FDA approve a new drug for sale and marketing in the USA.

For successful FDA approval, what content and format requirements are necessary to comply with FDA guidelines? How do you plan your submission timetable?

This module provides regulatory professionals with the requirements to complete and submit NDAs for FDA approval.

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