FDA
3rd July 2014

FDA AdComm Roll Call – Several Committee Changes for the Summer!

It’s getting hot outside, but that’s not stopping the FDA from making a lot of changes to their advisory committee rosters! Several committee members have come to the end of their terms while others are just starting as new committee members. 

FDA AdComm Roll Call – Several Committee Changes for the Summer!

It’s getting hot outside, but that’s not stopping the FDA from making a lot of changes to their advisory committee rosters! Several committee members have come to the end of their terms while others are just starting as new committee members.

Last month, the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) saw the departure of four of its members; Vera Bittner, MD, Erica Brittain, PhD, Edwards Gregg, PhD and Ellen Seely, MD. Robert Smith, MD has been selected as the new chair of this committee. Additionally, Peter Wilson, MD has joined the committee. He is an expert of Cardiology, Endocrinology and Public Health at Atlanta Veterans Affairs Medical Center and Professor at Emory University in Georgia. Now there are 4 vacancies to be filled on this committee.

The Gastrointestinal Drugs Advisory Committee (GIDAC) saw the departure of Gagan Sood, MD and Marc Wishingrad, MD. Two new members have been added to this team, leaving 0 vacancies to fill:

  • Linda Feagins, MD: expert in Gastroenterology-Inflammatory Bowel Disease at Dallas Veterans Affairs Medical Center
  • David Keljo, MD, PhD: expert in Pediatric Gastroenterology at the Children’s Hospital of Pittsburgh

The Oncologic Drugs Advisory Committee’s (ODAC) current member, Deborah Armstrong, MD was selected as the new chair. Mikkael Sekeres, MD, Frank Balis, MD, Julie Vose, MD and Antoinette Wozniak, MD left the committee as their terms came to an end. No new individuals have been selected to join the committee as of yet, leaving a total of five vacancies to be filled.

The Pulmonary-Allergy Drugs Advisory Committee (PADAC) saw the departure of their chairperson, David Jacoby, MD, in addition to three other members; Steven Shapiro, MD, Kelly Dean Stone, MD, PhD, and Judith Voynow, MD. No replacements have been found thus far.

Finally, the Bone, Reproductive & Urologic Drugs Advisory Committee (BRUDAC) saw the departure of Richard Bockman, MD, PhD, Kathleen Hoegger, MD, MPH, Valerie Montgomery Rice, MD and Michele Orza, ScD, the committee’s consumer representative. Vivian Lewis, MD has been selected to join the committee. She is an expert in Obstetrics & Gynecology at the University of Rochester in New York State.

Stay tuned for our next AdComm Roll Call Special where we will put the spotlight on the Nonprescription Drugs Advisory Committee (NPDAC)!

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComms per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net

Interested in learning about ISS’ expert approach to Advisory Committee Meeting preparation? Click below in order to find out for yourself! 

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