This month we saw the addition of 4 new members to the Anti-infective Drugs Advisory Committee! This committee is now only has 1 vacancy. The new members are:

• Antonio Carlos Arrieta, M.D., an expert of Pediatric Infectious Diseases and Chief at the Division of Infectious Diseases of
  Children’s Hospital of Orange County.
• Marc H. Scheetz, PharmD, MSc, an expert in Infectious Disease Pharmacology and an Associate Professor of Pharmacy Practice at 
  Midwestern University Chicago College of Pharmacy.
• Alan J. Magill, M.D., an expert in Infectious Diseases and Director, Malaria at the Bill and Melinda Gates Foundation.
• Luis Z. Ostrosky, M.D., also an Infectious Diseases expert. Dr. Ostrosky is a Professor of Medicine and Epidemiology in the Division of Infectious Diseases at the University of Texas Medical School at Houston.

The Ani-infective Drugs Advisory Committee is scheduled for two meetings for the month of October. Click HERE to view the meeting announcement for one of their meetings regarding the safety and effectiveness of the new drug application (NDA) 204684 for miltefosine capsules, submitted by Paladin Therapeutics, Inc. Click HERE to view the entire FDA Advisory Committee Calendar!

4 new members were also added to the Drug Safety and Risk Management Advisory Committee. The new members are:

• Tobias Gerhard, PhD, RPh, an expert of Pharmacoepidemiology and Assistant Professor at Rutgers University’s Department of Pharmacy Practice and Administration.
• Linda Tyler, PharmD, FASHP, an expert in Medication Safety and Pharmacy Practice. She is also the Administrative Director of Pharmacy Services at University of Utah Hospitals & Clinics and is a Clinical Professor and Associate Dean for Pharmacy Practice.
• Andy S. Stergachis, PhD, RPh, an expert in Epidemiology and Professor of Epidemiology and Global Health
  Director in the Global Medicines Program at the University of Washington School of Public Health.
• Til Stürmer, MD, MPH, PhD, is an expert in Pharmacoepidemiology and Professor at The University of North Carolina at Chapel Hill.

Dr. Bart Clarke departed from the Reproductive Health Drugs Advisory Committee and was replaced by Amy H. Herring, ScD, leaving the number of vacancies the same.

Furthermore, we saw the additions of Stuart Rich, M.D. to the Cardiovascular and Renal Drugs Advisory Committee, Jessie L-S Au, Ph.D. to the Pharmaceutical Science and Clinical Pharmacology Advisory Committee, Bernard F. Cole, Ph.D. to the Oncologic Drugs Advisory Committee, and Diana Hallare, MPH to the Endorcrinologic and Metabolic Drugs Advisory Committee as a Consumer Representative.

Stay tuned for our next AdComm Roll Call Special where we will put the spotlight on the FDA’s one and only Dermatologic and Opthalmic Drugs 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

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