Print Edition - Preparing the New Drug Application: Managing Submissions Amid Changing Global Requirements

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March 2006

This book will bring you up to speed on recent changes to the NDA process — including the change from paper to electronic format — and guide you step-by-step through the application process. Whether you’re an industry veteran or newcomer, this book will help ensure that your new drug does indeed makeit to the marketplace.

Your NDA sets out the conditions that can spell the difference between commercial success and failure. In Preparing the New Drug Application, you’ll get comprehensive guidance on how to:

  • Prepare for and conduct the critical pre–NDA meeting with FDA staff
  • Create and submit a common technical document
  • Prepare a biologic license application in common technical document format.
  • Put together an abbreviated new drug application
  • Prepare a 505(b)(2) or 505(j) application for a generic version of a branded drug
  • Assemble paper submissions
  • Prepare for all–important FDA advisory committee meetings
  • Prepare an NDA for an orphan drug
  • Convert NDAs into common technical documents for European filings
William Sietsema is a senior director at Kendle International. He played a pivotal role in the fast-track development of Pharmacia's Celebrex, which transited from beginning of Phase II to NDA approval in less than three years. He has a PhD in biochemistry from the University of Wisconsin and is the author of two books, one of which was published by FDAnews. He is also a member of the American Chemical Society, the American Society for Bone and Mineral Research, the Inflammation Research Association, the American College of Rheumatology, the Arthritis Foundation, the Endocrine Society and the International Association for the Study of Pain.

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