PDF Edition - Cut Drug Approval Time with a 505(b)(2)

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Cut Drug Approval Time
with a 505(b)(2)

Unsure of how to use the 505(b)(2) process?

Here's an opportunity to get all the details in a new report available from FDAnews.

A 505(b)(2) can provide relatively fast-track approval for a wide range of products, especially for those that represent a limited change from an existing or approved drug. Ideal candidates include:

  • New chemical entities (NCEs)/new molecular entities (NMEs)
  • Changes to previously approved drugs
     

  • Changes in dosage form, strength or route of administration
     

  • Changes from prescription (Rx) indications to over-the-counter (OTC) indications
     

  • Substitution of an active ingredient in a combination product
     

Of course, the devil is in the details — and that's why this report with valuable tips from Kurt Karst, Director with Hyman, Phelps & McNamara,and a widely respected legal authority and blogger on 505(b)(2) issues — is a must have.  Readers will learn:

  • How the 505(b)(2) is similar to and differs from the 505(b)(1) standard NDA and the 505(j) ANDA
  • How drugs approved under the 505(b)(2) process can obtain either three or five years of patent exclusivity
  • When applications involving changes to approved drugs can use the 505(b)(2) pathway
  • How to choose a listed drug for a 505(b)(2) application
  • About FDA interpretations of the law affecting 505(b)(2) applications
  • About fees and restrictions involved in using the 505(b)(2) process
  • And more

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Table of Contents

  • Ways to Use the 505(b)(2)
  • 505(b)(2) Patent and Exclusivity Protections
  • FDA Interpretations
  • Recent Challenges Concerning 505(b)(2)s

View the entire TOC

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Kurt Karst, a Director with Hyman, Phelps & McNamara, is a widely respected legal authority and blogger on 505(b)(2) issues. Karst provides regulatory counseling to pharmaceutical manufacturers concerning Hatch-Waxman patent and exclusivity issues, myriad drug development issues, pediatric testing issues and orphan drug issues. Previously, he was a lobbyist for F. Hoffman-La Roche Inc.

Mr. Karst served as an articles editor for the American University Law Review, and in 1995, was awarded a Fulbright Scholarship for post-graduate studies in Germany. He has published in the American University Law Review, the Food and Drug Law Journal and Update, RAPS FOCUS and many other publications, and is co-author of the Food and Drug Law Institute's Drug and Biologic Approvals: The Complete Guide for Small Businesses — FDA Financial Assistance and Incentives.

  • Drug company executives
  • Regulatory affairs officers
  • Compliance officers

Get Multi-user Access With The Electronic Books Library.
Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the Electronic Books Library – a personalized collection of FDAnews publications that is fully searchable. Contact customer service for a quote or more information.

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