The proposed GDUFA II fee model contains a number of new elements, including a reduced-fee CMO tier for FDF Facility Fees, and an ANDA Holder Fee. How will these changes affect your company? Find out on February 21, 2017 in an exclusive PBOA/FDA webinar!

PBOA has invited FDA Division of User Fee officials Donal Parks and Gisa Perez to give a presentation on the changes proposed under GDUFA II, followed by Q&A. This free event is only for members of the Pharma & Biopharma Outsourcing Association!

In this one-hour webinar you will learn about:

  • the new GDUFA II fee model
  • how FDA defines CMO facilities under GDUFA II
  • the correct self-ID processes for facilities and ANDA holders
  • the potential penalties for misidentified facilities

Date: Tuesday, February 21, 2017

Time: 10:00 am to 11:00 am, EST

Speakers: Donal Parks is Director, Division of User Fee Management and Budget Formulation, Office of Management, CDER. Gisa Perez is Generics Branch Chief in the Division of User Fee Management and Budget Formulation.

Register today for this free, PBOA-members-only webinar on GDUFA II and CMOs! (And let us know what topics you would like them to cover!)

GDUFA II & CMOs Webinar Registration



(If you’re not a member of the PBOA and would like to attend this webinar, please contact us to learn about the benefits your CMO/CDMO can gain by joining PBOA!)