Accelerating Generic Drug Development: The FDA’s New Plan for Increasing Generic Competition

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FDA Commissioner Scott Gottlieb’s mission is to make it easier and faster to get generic drugs into the market. Speaking out against soaring drug prices and the games drug companies play to block generics, Gottlieb has developed a plan that aims to approve more generic drugs and do it faster than ever before.

The “rule of three” policy is that if a particular brand drug does not have 3 generic versions on the market, any application for a new generic will get priority review. 

Accelerating Generic Drug Development explains the FDA’s new policy and shows how to navigate the new pathway to approval. This is information every generic drug developer needs:

  • What brand name drugs are now available for generic development
  • The FDA’s new 8-month goal date for reviewing generic products for which there are no blocking patents or exclusivities and fewer than three approved ANDAs
  • The types of products the FDA wants to see developed
  • Rules for pre-submission facility correspondence with the agency
  • Guidance on the content and format of ANDA submissions
  • Changes to the REMS policy that require brand name and generic drug companies to develop a single shared REMS plan

In this report you’ll find information on:

  • How the commissioner’s plan aims to reduce pharma companies’ efforts to block generic drugs’ entry into the market
  • The “rule of three” — the FDA plans to prioritize the entry of new generic drugs until there are at least three competitors per reference listed drug
  • The difference between priority review and expedited review
  • How to request priority review
  • How the FDA’s new Competitive Generic Therapy (CGT) designation can accelerate development and review
  • What the FDA considers “complex” products and how the designation can gain additional agency assistance

Order your copy of Accelerating Generic Drug Development: The FDA’s New Plan for Increasing Generic Competition and understand how FDA Commissioner Scott Gottlieb’s Drug Competition and Action Plan opens new and competitive opportunities for generic drug approval.

About the Authors

Chad Landmon is a Partner and chairs the FDA and IP practice groups at Axinn, Veltrop & Harkrider LLP. He has extensive experience assisting pharmaceutical companies with bringing their products to market, including navigating the complex drug approval pathway at FDA. Chad's experience with FDA matters also includes litigation and advocacy surrounding generic drug marketing exclusivities and application approval standards.

Suchira Ghosh is Counsel in the FDA and IP practice groups at Axinn. She has considerable experience with FDA’s drug approval pathway and its various scientific, regulatory and legal challenges. She provides counseling related to FDA matters such as REMS, approval standards, and administrative dispute resolution.

Who Will Benefit

  • Regulatory department
  • R&D
  • Executive level planners

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Author:
Chad Landmon and Suchira Ghosh

ISBN-13:
978-1-60430-095-6

Publication date:

Page count:
307


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