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CDER Director Woodcock, 27 U.S. FDA Speakers Confirmed for 2014 PDA/FDA Joint Regulatory Conference

For Immediate Release:
06/18/2014
Media Inquiries:
Walt Morris
/ morris@pda.org /
301-656-5900, x. 148

Bethesda, Md., June 18, 2014  – The Parenteral Drug Association has confirmed the participation of 27 officials from the U.S. FDA, including CDER Director Janet Woodcock, MD, as speakers at the 2014 PDA/FDA Joint Regulatory Conference. Besides the Center for Drug Evaluation and Research (CDER), the FDA Centers for Biologics Evaluation and Research (CBER),  Devices and Radiological Health (CDRH), and Veterinary Medicine (CVM), along with the Office of Regulatory Affairs (ORA), will be represented on the podium during the conference.

“PDA membership works in a wide range of industries, so it is important they hear the viewpoints from officials in the various centers,” said PDA President Richard Johnson. “It is also critical that our members understand the latest Agency initiatives in order to be able to perform effectively for their companies, and have the opportunity to interact with key regulators to ask questions and understand the background and various perspectives.”

The following is a list of the confirmed FDA speakers, alphabetically listed with their center/office indicated:

  • Jeffrey Baker, CDER
  • Kimberly Benton, PhD, CBER
  • Ilisa Bernstein, CDER
  • Monica Caphart, ORA
  • David Cummings, CDER
  • Gerald Dal Pan, CDER
  • Bernadette Dunham, D.V.M, PhD, CVM
  • Carl Fischer, CDRH
  • Richard Friedman, CDER
  • Martine Hartogensis, CVM
  • Mai Huynh, CVM
  • Robert Iser, CDER
  • Valerie Jensen, R. Ph, CDER
  • Steve Kozlowski, MD, CDER
  • Rapti Madurawe, PhD, CDER
  • Mary Malarkey, CBER
  • Karen Midthun, PhD, CBER
  • Ann Marie Montemurro, ORA
  • Alicia Mozzachio, CDER
  • Laurie Norwood, CBER
  • Thomas O’Connor, PhD, CDER
  • Mahesh Ramanadham, CDER
  • Carol Rehkopf, CBER
  • Steven Silverman, CDRH
  • Steven Solomon, ORA
  • Douglas Stearn, ORA
  • Janet Woodcock, MD, CDER