Expediting the Generic Drug Approval Process - Webinar Recording/Transcript

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Expediting the Generic Drug Approval Process: FDA’s New Initiatives on Drug Competition

The FDA announced its Drug Competition Action Plan a year ago. And the agency continues to announce new guidances intended to speed up generic drug approvals. The FDA recently announced a guidance to enhance filing review requirements.

A record number of generic drugs have been approved this year. With the new expediting process, Commissioner Gottlieb believes that record highs will be achieved year on year.

Are you — and your new generic — ready for the expedited pathway?

In 90 fast-paced minutes attorneys Chad Landmon and Suchira Ghosh of Axinn, Veltrop & Harkrider LLP will methodically lay out the various policies, how they’ve been implemented, how you can engage with them and identify possible issues. You’ll learn the following:

  • The new pathways to expedite approval of generic drug applications, including 180-day exclusivity
  • Best practices to obtain exclusivity and the top don’ts for losing exclusivity
  • Recent FDA policy statements and guidance on generic drugs and their impact on regulatory and quality professionals
  • Substantive changes to REMS standards that impact ANDAs
  • FDA’s other policy initiatives: prioritizing generic drug review; spur generic approvals to increase competition and lower cost, while maintaining quality
  • How the real cost saving benefit provided by generics doesn’t come into full effect until there are multiple generic versions available

Order today to gain a clearer understanding of the various FDA initiatives surrounding generic drug access and how to best navigate these changes.

  • Regulatory Counsel
  • Regulatory Affairs
  • Safety and Pharmacovigilance
  • REMS manager
  • Legislative and Policy

Meet Your Presenters

Chad Landmon, Partner, Axinn, Veltrop & Harkrider LLP
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, Counsel, Axinn, Veltrop & Harkrider LLP
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.