FDA
8th September 2014

AdComm Roll Call Special – FDA is Ready for Fall!

The Arthritis Advisory Committee (AAC) is down to only one vacancy after the latest additions of Drs. Caplan and Reimold; both experts in rheumatology. Dr. LirThe Anti-Infective Drugs Advisory Committee (AIDAC) welcomed Dr. Lindsay Baden to the committee and is now at capacity with no more vacancies. Dr. Baden is Director of Clinical Research in the Division of Infectious Diseases at Brigham and Women’s Hospital in Boston, MA.

AdComm Roll Call Special – FDA is Ready for Fall!

With summer coming to a close we saw the FDA add a few more members to various committees to kick-off a busy fall season of meetings.

The Arthritis Advisory Committee (AAC) is down to only one vacancy after the latest additions of Drs. Caplan and Reimold; both experts in rheumatology. Dr. LirThe Anti-Infective Drugs Advisory Committee (AIDAC) welcomed Dr. Lindsay Baden to the committee and is now at capacity with no more vacancies. Dr. Baden is Director of Clinical Research in the Division of Infectious Diseases at Brigham and Women’s Hospital in Boston, MA.

on Caplan is an Associate Professor of Medicine at the University of Colorado and Dr. Andreas Reimold is the Chief of Rheumatology at the Dallas VA Medical Center.

The Psychopharmacologic Drugs Advisory Committee (PDAC) has added one new member, dropping their vacancy to three. Dr. David Pickar, an expert in neuropharmacology started his four year tenure with the committee this month. Dr. Pickar is an Adjunct Professor of Psychiatry at Johns Hopkins Medical School.

Lastly, we saw some changes this month to the Pulmonary-Allergy Drugs Advisory Committee (PADAC). Dr. Dennis Ownby is now the committee’s chair and Drs. Morrato and Grayson both joined the committee. PADAC is now at zero vacancies. Dr. Elaine Morrato is an epidemiologist with expertise in drug safety and risk management. She is currently an Associate Professor in the Department of Health Systems, Management and Policy at the Colorado School of Public Healthy. Dr. Mitchell Grayson is a trained allergist/immunologist and is an Associate Professor of Pediatrics, Medicine, Microbiology and Molecular Genetics at the Medical College of Wisconsin.

Stay tuned for our next AdComm Roll Call Special where we will put the spotlight on the Anesthetic and Analgesic Drug Products 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 Meeting preparation? Click below in order to find out for yourself

Generic Blog CTA for Ad Comm Approach

Recent Related Articles

Best Tips for Medical Device Manufacturers to Write a Compelling Substantial Equivalence Section for their FDA 510k Submission
01 July 2020
Best Tips for Medical Device Manufacturers to Write a Compelling Substantial Equivalence Section for their FDA 510k Submission

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

Evolving FDA Thinking on Advisory Committee Meetings Related to Foods, Drugs, and Devices
25 June 2020
Evolving FDA Thinking on Advisory Committee Meetings Related to Foods, Drugs, and Devices

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

NDA vs. OTC Monograph: Which Pathway is Right for You?
22 June 2020
NDA vs. OTC Monograph: Which Pathway is Right for You?

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

4 Problems Importing Rapid Antibody Tests for Coronavirus
19 June 2020
4 Problems Importing Rapid Antibody Tests for Coronavirus

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

Let’s work together

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