FDA
6th August 2014

AdComm Roll Call – Looks Like a Busy Fall for the FDA!

With a busy AdComm calendar coming up this fall, it is no surprise FDA is finalizing changes to their advisory committee rosters. Several committee members have come to the end of their terms and other committees have filled some vacancies.

AdComm Roll Call – Looks Like a Busy Fall for the FDA!

With a busy AdComm calendar coming up this fall, it is no surprise FDA is finalizing changes to their advisory committee rosters. Several committee members have come to the end of their terms and other committees have filled some vacancies.

The Medical Imaging Drugs Advisory Committee (MIDAC) saw the departure of Dr. Jersey Chen and the vacancy was immediately filled by Dr. Nicholas Dainiak. Dr. Dainiak is an expert in hematology and radiation countermeasures and is a Clinical Professor of Internal Medicine at the Yale University School of Medicine. The Oncologic Drugs Advisory Committee (ODAC) was looking a bit sparse with five vacancies. Two of those spots were filled last month with Drs. Burstein and Roth.  Dr. Burstein is an Associate Professor of Medicine at Harvard Medical School and Dr. Roth is a Professor of Medicine at Washington University School of Medicine.The Cardiovascular and Renal Drugs Advisory Committee (CRDAC) saw the departure of Drs. Emerson and Papdemetriou. The committee now has four vacancies. The Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) filled its only vacancy last month with Dr. Jeffrey Galinkin. Dr. Galinkin is a Professor of Anesthesiology and Pediatrics at the University of Colorado, AMC and Director of Scientific and Medical Affairs at CPC Clinical Research.

The Peripheral and Central Nervous System Drugs Advisory Committee (PCNSDAC) also rounded out their roster and now have no vacancies. Joining the committee is a new chair Dr. George Alexander, Associate Professor of Epidemiology and Medicine at Johns Hopkins School of Public Health. The other two spots were filled by Drs. Nicole R. Gonzales and Bruce I. Ovbiagele.

Lastly, the Psychopharmacologic Drug Advisory Committee (PDPAC) saw a departure of three committee members including the Chair, Dr. David Brent. Drs. Luby and Stein have also finished their terms leaving 4 total vacancies on the committee.

Stay tuned for our next AdComm Roll Call Special where we will put the spotlight on the Psychopharmacologic Drugs Advisory Committee in hopes they fill some of those empty seats!

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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