This month we saw the departure of seven members and the addition of a total of 15 new members to the FDA Drug Advisory Committees. The committees that welcomed new members include the Anesthetic Drug Products Advisory Committee (AADP), the Antiviral Drugs Advisory Committee (AVD), the Pharmaceutical Science and Clinical Pharmacology Advisory Committee, and the Psychopharmacologic Drugs Advisory Committee.
This month we saw the departure of seven members and the addition of a total of 15 new members to the FDA Drug Advisory Committees. The committees that welcomed new members include the Anesthetic Drug Products Advisory Committee (AADP), the Antiviral Drugs Advisory Committee (AVD), the Pharmaceutical Science and Clinical Pharmacology Advisory Committee, and the Psychopharmacologic Drugs Advisory Committee.
The AADP welcomed five new members, filling five of six open spots. This committee is now down to just one vacancy and the new members include:
The AVD saw the departure of four members, whose terms expired at the end of October. The committee wasted no time and immediately welcomed four new members:
Leaving the Pharmaceutical Science and Clinical Pharmacology Advisory Committee were three members. Four more joined the committee which brings the total number of vacancies down from 18 to 17. The four new members include:
We also saw the addition of Dr’s Battisti and Maddock to the Psychopharmacologic Drugs Advisory Committee. John J. Battisti, Ph.D., R.Ph.’s expertise is in Neuropharmacology and he is currently an Associate Professor of Clinical Sciences at the College of Pharmacy of Calilfornia Northstate University. Richard J. Maddock, M.D. is a Psychiatrist and is currently a Professor at the University of California Davis. The number of vacancies in this committee is now down from five to three.
Want to stay up to date on the members of the FDA Drug Advisory Committees?
Subscribe to the ISS AdComm Blog now!
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
Over the past few years, the number of ex-US manufacturers submitting a Class II exempt 510k device registration has increased substantially. For companies with medical devices that are approved and successful in a foreign market, the logical next step is to introduce their product into the US, which has one of the most lucrative healthcare markets in the world. Read more
FDA advisory committee meetings are important regulatory events for many manufacturers on the path to marketing approval. These meetings can quite literally result in the approval or rejection of a product based on the panel’s vote. Read more
One of the main challenges our clients face is determining which regulatory pathway is best for their products. For example, what if an OTC product has a Monograph active ingredient but that ingredient is present at a different amount than the permitted amount? Or what if the label claims a novel indication not specified in a Monograph? If you are debating pursuit of either regulatory pathway for your OTC drug, it is critical to consider cost, timeline, and label claims to ensure your products has a unique stance in today’s market. Read more
US distributors and agents trying to import rapid antibody tests for coronavirus face a number of obstacles. The good news is that FDA has opened up the Emergency Use Authorization (EUA) program to include SARS-CoV-2 (the virus) and COVID-19 (the disease), expediting time to market. Read more
The journey to scientific and commercial success is often complex and always critical, if you are looking for an expert partner to help steer you to confident solutions, contact us today
Contact us