October 16, 2013 8:00 a.m. to 5:00 p.m.: Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee.
The committee will discuss the supplemental new drug application, NDA 202057/S-005, Vascepa (icosapent ethyl) Capsules, submitted by Amarin Pharmaceuticals Ireland Ltd. Vascepa is currently approved as monotherapy for the treatment of severe hypertriglyceridemia. This supplemental application proposes concomitant use with an inhibitor of HMG-CoA reductase (statin) to reduce triglycerides (TG), non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (Apo B), low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC) and very-low-density lipoprotein cholesterol (VLDL-C) in adults with mixed dyslipidemia and coronary heart disease (CHD) or a CHD risk equivalent.
Please click HERE to access the FDA meeting materials associated with this meeting. In the meeting materials, you will find the original meeting announcement, the agenda, committee roster(s), webcast information, FDA proposed questions and other relevant briefing information.
Please click HERE to view this meeting’s original announcement.
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 email@example.com.
Interested in learning about ISS’ expert approach to Advisory Committee Meetings? Click below in order to find out for yourself!
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 todayContact us