FDA
6th September 2013

FDA AdComm Roll Call – Vacancies Filled!

This month we saw the addition of 4 members to the Pulmonary-Allergy Drugs Advisory Committee– which means that this committee nearly doubled! This committee is now down from 8 to 4 vacancies and the new members include:

FDA AdComm Roll Call – Vacancies Filled!

This month we saw the addition of 4 members to the Pulmonary-Allergy Drugs Advisory Committee– which means that this committee nearly doubled! This committee is now down from 8 to 4 vacancies and the new members include:

  • John E. Connett,Ph.D., an expert  and Professor in biostatistics at the School of Public Health, Coordinating Centers for Biometric Research at the University of Minnesota.
  • Michelle S. Harkins, M.D., FCCP, an expert in pulmonary/critical care medicine and an Associate Professor of Medicine at the University of New Mexico.
  • Nizar N. Jarjour, M.D., also an expert in pulmonary/critical care medicine and a Professor and Head of the section of Allergy, Pulmonary and Critical Care of the University of Wisconsin-Madison School of Medicine and Public Health.
  • James M. Tracy, DO, whose expertise is in allergy and immunology. He is an Assistant Clinical Professor of internal medicine at the Creighton University School of Medicine, and also a Managing Partner of Allergy Asthma & Immunology Associates, P.C. in Omaha, Nebraska.

We also saw the addition of Raymond Y. Kwong, M.D., M.P.H. to the Medical Imaging Drugs Advisory Committee (MIDAC). Dr. Kwong’s expertise is in cardiology and cardiac magnetic resonance. He is an Associate Professor of Medicine at Harvard Medical School and also the Director of Cardiac Magnetic Resonance Imaging and Brigham and Women’s Hospital in Boston, Massachusetts. Dr. Kwong filled 1 of the 2 vacancies remaining on this committee.

In the Endocrinologic and Metabolic Drugs Advisory Committee (EMAC), we saw the term expiration and departure of Drs. David M. Capuzzi and Ida L. Spruill. Dr. Spruill served as the consumer representative for EMAC. They have yet to be replaced.

Stay tuned for our next blog post where we will put the spotlight on one of the hottest committees– the Drug Safety and Risk Management Advisory Committee

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

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