United States: New FDA Final Rule On Abbreviated New Drug Applications And 505(B)(2) Applications: What You Need To Know
Last Updated: November 3 2016

On December 5, 2016, the FDA's newest final rule on ANDAs and 505(b)(2) applications will become effective. This presentation will make sure you stay up to date on the changes to the FDA's regulations, especially as they may impact Hatch-Waxman Act litigations. Topics will include:

  • Changes to Orange Book listings and procedures, including use codes, expansion of the category of "untimely filed patent information," and challenges to listed patent information;
  • Changes to Paragraph IV Certifications, including new limitations on the timeframe in which notice can be provided, and revisions to the content of the Certifications may be made;
  • The FDA's new requirement for 505(b)(2) applications, which is designed to ensure that such applications don't circumvent patent certification obligations.

There is no charge to attend this program. Please register by Wednesday, November 9, 2016. Webinar access and dial-in information will be sent upon registration.

Scheduling Conflict? Finnegan records all hosted webinars. To view the recorded program, simply register for the webinar and you will receive an access link shortly after the live program is complete.


Jonathan R. Davies, Ph.D.

Barbara R. Rudolph, Ph.D.
Robert C. Stanley

Thursday, November 10, 2016

10:00 - 11:00 a.m. PST
1:00 - 2:00 p.m. EST

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