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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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